Trial Outcomes & Findings for A Study of Lebrikizumab (LY3650150) in Combination With Topical Corticosteroids in Japanese Participants With Moderate-to-Severe Atopic Dermatitis (NCT NCT04760314)

NCT ID: NCT04760314

Last Updated: 2023-08-23

Results Overview

The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 286 participants
• Primary outcome timeframe: Baseline to Week 16
• Results posted on: 2023-08-23

Participant Flow

Induction period (16-weeks): Participants were randomly assigned to 250mg Lebrikizumab every 2 weeks (Q2W) or 250mg Lebrikizumab every 4 weeks (Q4W) or Placebo. Maintenance period (52-weeks): At week 16, responders from 250mg Lebrikizumab Q2W were re-randomised to 250mg Lebrikizumab Q2W and 250mg Lebrikizumab Q4W; responders from 250mg Lebrikizumab Q4W or Placebo arms continued with same treatment. Responders were defined as having an IGA of 0 or 1 or a 75% reduction in EASI (EASI-75).

(continued) Escape arm: Induction non-responder (i.e.) participants who do not achieve an IGA of 0 or 1 or an EASI-75 at Week 16 and maintenance non-responders (i.e.) those not maintaining an EASI-50 response at week 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, or 64 following week 16 were assigned to an Escape Arm and received lebrikizumab 250 mg as open-label treatment Q2W through Week 68. Throughout the trial, participants received the study drug in combination with topical corticosteroid.

Participant milestones

Measure	Induction - Placebo Induction Period: (Baseline - Week 16): Participants received two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection Q2W from Week 4 until Week 14.	Induction - Lebrikizumab 250mg Q4W Induction Period (Baseline - Week 16): Participants received 500 mg of Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline followed by 250 mg of Lebrikizumab administered SC Q4W from Week 4 until Week 12.	Induction - Lebrikizumab 250mg Q2W Induction Period (Baseline - Week 16): Participants received 500 mg of Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 followed by 250 mg of Lebrikizumab administered SC Q2W from Week 4 until Week 14.	Maintenance Blinded Period - Placebo Responder/Placebo Maintenance Secondary Population: Maintenance Period (Week 16 - Week 68): Participants received Placebo administered SC Q2W from Week 16 to Week 66.	Maintenance Blinded Period - Lebrikizumab Q4W Responder/Lebrikizumab Q4W Maintenance Primary Population: Maintenance Period (Week 16 - Week 68): Participants received 250 mg Lebrikizumab administered SC Q4W from Weeks 16 until Week 64.	Maintenance Blinded Period - Lebrikizumab Q2W Responder/ Lebrikizumab Q4W Maintenance Primary Population: Maintenance Period (Week 16 - Week 68): Participants received 250 mg Lebrikizumab administered SC Q4W from Week 16 until Week 64.	Maintenance Blinded Period - Lebrikizumab Q2W Responder/Lebrikizumab Q2W Maintenance Period (Week 16 - Week 68): Participants received 250 mg of Lebrikizumab administered SC Q2W from Week 16 until Week 66.	Escape Arm Week 16 - Maintenance Open Label - Placebo Non Responder/Lebrikizumab 250 mg Q2W Participants received blinded doses based on prior treatment assignment followed by one 250 mg Lebrikizumab administered SC Q2W until Week 68 in an open-label fashion. For participants who received placebo in the Induction Period, loading dose was: Two 250 mg Lebrikizumab SC injection on Week 16 and two 250 mg Lebrikizumab SC injections on Week 18. For participants who did not maintain an acceptable response during the Maintenance Period and entered the Escape Arm, the loading doses were administrated at entry and 2 weeks after entry based on the treatment assignment prior to entering escape arm.	Escape Arm Week 16 Maintenance Open Label-Lebrikizumab 250mg Q4W Nonresponder/Lebrikizumab 250mg Q2W Participants received blinded doses based on prior treatment assignment followed by one 250 mg Lebrikizumab administered SC Q2W until Week 68 in an open-label fashion. For participants who received Lebrikizumab Q4W in the Induction Period, the loading dose was: One 250 mg Lebrikizumab administered SC on Week16 and Week 18. For participants who did not maintain an acceptable response during the Maintenance Period and entered the Escape Arm, the loading doses were administrated at entry and 2 weeks after entry based on the treatment assignment prior to entering escape arm.	Escape Arm Week 16 Maintenance Open Label-Lebrikizumab 250mg Q2W Nonresponder/Lebrikizumab 250mg Q2W Participants received blinded doses based on prior treatment assignment followed by one 250 mg Lebrikizumab administered SC Q2W until Week 68 in an open-label fashion. For participants who received Lebrikizumab Q2W in the Induction Period, the loading dose was: One 250 mg Lebrikizumab administered SC on Week16 and Week 18. For participants who did not maintain an acceptable response during the Maintenance Period and entered the Escape Arm, the loading doses were administrated at entry and 2 weeks after entry based on the treatment assignment prior to entering escape arm.	Escape Arm Week 20 to 64 Maintenance Open Label Lebrikizumab 250 Q2W Participants received 250 mg Lebrikizumab administered SC Q2W through Week 68 in an open-label fashion.
Induction Period STARTED	82	81	123	0	0	0	0	0	0	0	0
Induction Period Received at Least One Dose of Study Drug	82	81	123	0	0	0	0	0	0	0	0
Induction Period COMPLETED	82	80	120	0	0	0	0	0	0	0	0
Induction Period NOT COMPLETED	0	1	3	0	0	0	0	0	0	0	0
Maintenance Blinded Period STARTED	0	0	0	11	38	33	32	0	0	0	0
Maintenance Blinded Period Received at Least One Dose of Study Drug	0	0	0	11	38	33	32	0	0	0	0
Maintenance Blinded Period COMPLETED	0	0	0	9	35	27	27	0	0	0	0
Maintenance Blinded Period NOT COMPLETED	0	0	0	2	3	6	5	0	0	0	0
Maintenance Open Label Escape Arm STARTED	0	0	0	0	0	0	0	71	42	55	8
Maintenance Open Label Escape Arm Received at Least One Dose of Study Drug	0	0	0	0	0	0	0	71	42	55	8
Maintenance Open Label Escape Arm COMPLETED	0	0	0	0	0	0	0	63	40	48	7
Maintenance Open Label Escape Arm NOT COMPLETED	0	0	0	0	0	0	0	8	2	7	1

Reasons for withdrawal

Measure	Induction - Placebo Induction Period: (Baseline - Week 16): Participants received two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection Q2W from Week 4 until Week 14.	Induction - Lebrikizumab 250mg Q4W Induction Period (Baseline - Week 16): Participants received 500 mg of Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline followed by 250 mg of Lebrikizumab administered SC Q4W from Week 4 until Week 12.	Induction - Lebrikizumab 250mg Q2W Induction Period (Baseline - Week 16): Participants received 500 mg of Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 followed by 250 mg of Lebrikizumab administered SC Q2W from Week 4 until Week 14.	Maintenance Blinded Period - Placebo Responder/Placebo Maintenance Secondary Population: Maintenance Period (Week 16 - Week 68): Participants received Placebo administered SC Q2W from Week 16 to Week 66.	Maintenance Blinded Period - Lebrikizumab Q4W Responder/Lebrikizumab Q4W Maintenance Primary Population: Maintenance Period (Week 16 - Week 68): Participants received 250 mg Lebrikizumab administered SC Q4W from Weeks 16 until Week 64.	Maintenance Blinded Period - Lebrikizumab Q2W Responder/ Lebrikizumab Q4W Maintenance Primary Population: Maintenance Period (Week 16 - Week 68): Participants received 250 mg Lebrikizumab administered SC Q4W from Week 16 until Week 64.	Maintenance Blinded Period - Lebrikizumab Q2W Responder/Lebrikizumab Q2W Maintenance Period (Week 16 - Week 68): Participants received 250 mg of Lebrikizumab administered SC Q2W from Week 16 until Week 66.	Escape Arm Week 16 - Maintenance Open Label - Placebo Non Responder/Lebrikizumab 250 mg Q2W Participants received blinded doses based on prior treatment assignment followed by one 250 mg Lebrikizumab administered SC Q2W until Week 68 in an open-label fashion. For participants who received placebo in the Induction Period, loading dose was: Two 250 mg Lebrikizumab SC injection on Week 16 and two 250 mg Lebrikizumab SC injections on Week 18. For participants who did not maintain an acceptable response during the Maintenance Period and entered the Escape Arm, the loading doses were administrated at entry and 2 weeks after entry based on the treatment assignment prior to entering escape arm.	Escape Arm Week 16 Maintenance Open Label-Lebrikizumab 250mg Q4W Nonresponder/Lebrikizumab 250mg Q2W Participants received blinded doses based on prior treatment assignment followed by one 250 mg Lebrikizumab administered SC Q2W until Week 68 in an open-label fashion. For participants who received Lebrikizumab Q4W in the Induction Period, the loading dose was: One 250 mg Lebrikizumab administered SC on Week16 and Week 18. For participants who did not maintain an acceptable response during the Maintenance Period and entered the Escape Arm, the loading doses were administrated at entry and 2 weeks after entry based on the treatment assignment prior to entering escape arm.	Escape Arm Week 16 Maintenance Open Label-Lebrikizumab 250mg Q2W Nonresponder/Lebrikizumab 250mg Q2W Participants received blinded doses based on prior treatment assignment followed by one 250 mg Lebrikizumab administered SC Q2W until Week 68 in an open-label fashion. For participants who received Lebrikizumab Q2W in the Induction Period, the loading dose was: One 250 mg Lebrikizumab administered SC on Week16 and Week 18. For participants who did not maintain an acceptable response during the Maintenance Period and entered the Escape Arm, the loading doses were administrated at entry and 2 weeks after entry based on the treatment assignment prior to entering escape arm.	Escape Arm Week 20 to 64 Maintenance Open Label Lebrikizumab 250 Q2W Participants received 250 mg Lebrikizumab administered SC Q2W through Week 68 in an open-label fashion.
Induction Period Withdrawal by Subject	0	1	1	0	0	0	0	0	0	0	0
Induction Period Adverse Event	0	0	2	0	0	0	0	0	0	0	0
Maintenance Blinded Period Withdrawal by Subject	0	0	0	1	2	1	2	0	0	0	0
Maintenance Blinded Period Enrolled to Escape Arm	0	0	0	1	0	4	3	0	0	0	0
Maintenance Blinded Period Assigned Treatment by Mistake	0	0	0	0	1	0	0	0	0	0	0
Maintenance Blinded Period Protocol Deviation	0	0	0	0	0	1	0	0	0	0	0
Maintenance Open Label Escape Arm Withdrawal by Subject	0	0	0	0	0	0	0	1	0	1	1
Maintenance Open Label Escape Arm Lack of Efficacy	0	0	0	0	0	0	0	5	1	5	0
Maintenance Open Label Escape Arm Lost to Follow-up	0	0	0	0	0	0	0	2	0	0	0
Maintenance Open Label Escape Arm Adverse Event	0	0	0	0	0	0	0	0	1	1	0

Baseline Characteristics

A Study of Lebrikizumab (LY3650150) in Combination With Topical Corticosteroids in Japanese Participants With Moderate-to-Severe Atopic Dermatitis

Baseline characteristics by cohort

Measure	Induction - Placebo n=82 Participants Induction Period: (Baseline - Week 16): Participants received two SC injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection Q2W from Week 4 until Week 14.	Induction - Lebrikizumab 250 mg Q4W n=81 Participants Induction Period (Baseline - Week 16): Participants received 500 mg of Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline followed by 250 mg of Lebrikizumab administered SC Q4W from Week 4 until Week 12.	Induction - Lebrikizumab 250 mg Q2W n=123 Participants Induction Period (Baseline - Week 16): Participants received 500 mg of Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 followed by 250 mg of Lebrikizumab administered SC Q2W from Week 4 until Week 14.	Total n=286 Participants Total of all reporting groups
Age, Continuous	34.80 years STANDARD_DEVIATION 13.60 • n=113 Participants	37.80 years STANDARD_DEVIATION 12.02 • n=163 Participants	35.50 years STANDARD_DEVIATION 12.24 • n=160 Participants	36.00 years STANDARD_DEVIATION 12.59 • n=483 Participants
Sex: Female, Male Female	24 Participants n=113 Participants	25 Participants n=163 Participants	41 Participants n=160 Participants	90 Participants n=483 Participants
Sex: Female, Male Male	58 Participants n=113 Participants	56 Participants n=163 Participants	82 Participants n=160 Participants	196 Participants n=483 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=113 Participants	0 Participants n=163 Participants	0 Participants n=160 Participants	0 Participants n=483 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=113 Participants	0 Participants n=163 Participants	0 Participants n=160 Participants	0 Participants n=483 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	82 Participants n=113 Participants	81 Participants n=163 Participants	123 Participants n=160 Participants	286 Participants n=483 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=113 Participants	0 Participants n=163 Participants	0 Participants n=160 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Asian	82 Participants n=113 Participants	81 Participants n=163 Participants	123 Participants n=160 Participants	286 Participants n=483 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=113 Participants	0 Participants n=163 Participants	0 Participants n=160 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Black or African American	0 Participants n=113 Participants	0 Participants n=163 Participants	0 Participants n=160 Participants	0 Participants n=483 Participants
Race (NIH/OMB) White	0 Participants n=113 Participants	0 Participants n=163 Participants	0 Participants n=160 Participants	0 Participants n=483 Participants
Race (NIH/OMB) More than one race	0 Participants n=113 Participants	0 Participants n=163 Participants	0 Participants n=160 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=113 Participants	0 Participants n=163 Participants	0 Participants n=160 Participants	0 Participants n=483 Participants
Region of Enrollment Japan	82 Participants n=113 Participants	81 Participants n=163 Participants	123 Participants n=160 Participants	286 Participants n=483 Participants

PRIMARY outcome

Timeframe: Baseline to Week 16

Population: All randomized participants, even if the participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Markov Chain Monte Carlo Multiple Imputation (MCMC-MI) was used to handle missing data.

The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.

Outcome measures

Measure	Induction - Placebo n=82 Participants Induction Period: (Baseline - Week 16): Participants received two SC injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection Q2W from Week 4 until Week 14.	Induction - Lebrikizumab 250 mg Q4W n=81 Participants Induction Period (Baseline - Week 16): Participants received 500 mg of Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline followed by 250 mg of Lebrikizumab administered SC Q4W from Week 4 until Week 12.	Induction - Lebrikizumab 250 mg Q2W n=123 Participants Induction Period (Baseline - Week 16): Participants received 500 mg of Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 followed by 250 mg of Lebrikizumab administered SC Q2W from Week 4 until Week 14.
Percentage of Participants With an Investigators Global Assessment (IGA) Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 16	6.1 Percentage of participants Interval 0.9 to 11.3	29.1 Percentage of participants Interval 19.2 to 39.1	33.4 Percentage of participants Interval 25.0 to 41.8

PRIMARY outcome

Timeframe: Week 16

Population: All randomized participants, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. MCMC-MI was used to handle missing data.

The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent, i.e., percentage of skin affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI-75 score was obtained by weight-averaging these 4 scores and will range from 0 (none) to 72 (severe).

The EASI-75 responder is defined as a participant who achieves a ≥ 75% improvement from baseline in the EASI score.

Outcome measures

Measure	Induction - Placebo n=82 Participants Induction Period: (Baseline - Week 16): Participants received two SC injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection Q2W from Week 4 until Week 14.	Induction - Lebrikizumab 250 mg Q4W n=81 Participants Induction Period (Baseline - Week 16): Participants received 500 mg of Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline followed by 250 mg of Lebrikizumab administered SC Q4W from Week 4 until Week 12.	Induction - Lebrikizumab 250 mg Q2W n=123 Participants Induction Period (Baseline - Week 16): Participants received 500 mg of Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 followed by 250 mg of Lebrikizumab administered SC Q2W from Week 4 until Week 14.
Percentage of Participants Achieving Eczema Area Severity Index-75 (EASI-75) (≥75% Reduction in EASI Score) at Week 16	13.4 Percentage of participants Interval 6.0 to 20.8	47.2 Percentage of participants Interval 36.3 to 58.1	51.2 Percentage of participants Interval 42.3 to 60.1

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: All randomized participants, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. MCMC-MI was used to handle missing data.

The EASI assesses objective physician estimates of 2 dimensions of AD - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe).

Least Square (LS) Mean was calculated using ANCOVA model with treatment, stratification factors of geographic region, age group, baseline IGA score (IGA 3 versus 4) as fixed factors baseline value as covariate.

Outcome measures

Measure	Induction - Placebo n=82 Participants Induction Period: (Baseline - Week 16): Participants received two SC injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection Q2W from Week 4 until Week 14.	Induction - Lebrikizumab 250 mg Q4W n=81 Participants Induction Period (Baseline - Week 16): Participants received 500 mg of Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline followed by 250 mg of Lebrikizumab administered SC Q4W from Week 4 until Week 12.	Induction - Lebrikizumab 250 mg Q2W n=123 Participants Induction Period (Baseline - Week 16): Participants received 500 mg of Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 followed by 250 mg of Lebrikizumab administered SC Q2W from Week 4 until Week 14.
Percent Change in Eczema Area Severity Index (EASI) Score From Baseline to Week 16	-25.25 Percent change Standard Error 4.765	-59.74 Percent change Standard Error 4.920	-64.23 Percent change Standard Error 4.402

SECONDARY outcome

Timeframe: Week 16

Population: All randomized participants, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. MCMC-MI was used to handle missing data.

The EASI assesses objective physician estimates of 2 dimensions of AD - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe).

The EASI-90 responder is defined as a participant who achieves a ≥ 90% reduction from baseline in the EASI score.

Outcome measures

Measure	Induction - Placebo n=82 Participants Induction Period: (Baseline - Week 16): Participants received two SC injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection Q2W from Week 4 until Week 14.	Induction - Lebrikizumab 250 mg Q4W n=81 Participants Induction Period (Baseline - Week 16): Participants received 500 mg of Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline followed by 250 mg of Lebrikizumab administered SC Q4W from Week 4 until Week 12.	Induction - Lebrikizumab 250 mg Q2W n=123 Participants Induction Period (Baseline - Week 16): Participants received 500 mg of Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 followed by 250 mg of Lebrikizumab administered SC Q2W from Week 4 until Week 14.
Percentage of Participants Achieving EASI-90 at Week 16	9.8 Percentage of participants Interval 3.3 to 16.2	28.4 Percentage of participants Interval 18.6 to 38.3	34.3 Percentage of participants Interval 25.9 to 42.7

SECONDARY outcome

Timeframe: Baseline to Week 1

Population: All randomized participants, with a Baseline Itch NRS Score ≥4, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. MCMC-MI was used to handle missing data.

The Itch Numeric Rating Scale (NRS) is a an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable."

Outcome measures

Measure	Induction - Placebo n=60 Participants Induction Period: (Baseline - Week 16): Participants received two SC injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection Q2W from Week 4 until Week 14.	Induction - Lebrikizumab 250 mg Q4W n=59 Participants Induction Period (Baseline - Week 16): Participants received 500 mg of Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline followed by 250 mg of Lebrikizumab administered SC Q4W from Week 4 until Week 12.	Induction - Lebrikizumab 250 mg Q2W n=80 Participants Induction Period (Baseline - Week 16): Participants received 500 mg of Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 followed by 250 mg of Lebrikizumab administered SC Q2W from Week 4 until Week 14.
Percentage of Participants With an Itch Numeric Rating Scale (NRS) Score of ≥4-points at Baseline Who Achieve A ≥4-point Reduction From Baseline to Week 1	0 Percentage of participants Interval 0.0 to 0.0	0 Percentage of participants Interval 0.0 to 0.0	1.3 Percentage of participants Interval 0.0 to 3.7

SECONDARY outcome

Timeframe: Baseline to Week 2

Population: All randomized participants, with a Baseline Itch NRS Score ≥4, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. MCMC-MI was used to handle missing data.

The Itch Numeric Rating Scale (NRS) is a an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable."

Outcome measures

Measure	Induction - Placebo n=60 Participants Induction Period: (Baseline - Week 16): Participants received two SC injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection Q2W from Week 4 until Week 14.	Induction - Lebrikizumab 250 mg Q4W n=59 Participants Induction Period (Baseline - Week 16): Participants received 500 mg of Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline followed by 250 mg of Lebrikizumab administered SC Q4W from Week 4 until Week 12.	Induction - Lebrikizumab 250 mg Q2W n=80 Participants Induction Period (Baseline - Week 16): Participants received 500 mg of Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 followed by 250 mg of Lebrikizumab administered SC Q2W from Week 4 until Week 14.
Percentage of Participants With an Itch NRS Score of ≥4-points at Baseline Who Achieve A ≥4-point Reduction From Baseline to Week 2	0 Percentage of participants Interval 0.0 to 0.0	1.7 Percentage of participants Interval 0.0 to 5.0	3.8 Percentage of participants Interval 0.0 to 7.9

SECONDARY outcome

Timeframe: Baseline to Week 4

Population: All randomized participants, with a Baseline Itch NRS Score ≥4, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. MCMC-MI was used to handle missing data.

The Itch Numeric Rating Scale (NRS) is a an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable."

Outcome measures

Measure	Induction - Placebo n=60 Participants Induction Period: (Baseline - Week 16): Participants received two SC injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection Q2W from Week 4 until Week 14.	Induction - Lebrikizumab 250 mg Q4W n=59 Participants Induction Period (Baseline - Week 16): Participants received 500 mg of Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline followed by 250 mg of Lebrikizumab administered SC Q4W from Week 4 until Week 12.	Induction - Lebrikizumab 250 mg Q2W n=80 Participants Induction Period (Baseline - Week 16): Participants received 500 mg of Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 followed by 250 mg of Lebrikizumab administered SC Q2W from Week 4 until Week 14.
Percentage of Participants With an Itch NRS Score of ≥4-points at Baseline Who Achieve A ≥4-point Reduction From Baseline to Week 4	0 Percentage of participants Interval 0.0 to 0.0	8.5 Percentage of participants Interval 1.4 to 15.6	16.3 Percentage of participants Interval 8.2 to 24.3

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: All randomized participants, with a Baseline Itch NRS Score ≥4, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol. MCMC-MI was used to handle missing data.

The Itch Numeric Rating Scale (NRS) is a an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable."

Outcome measures

Measure	Induction - Placebo n=60 Participants Induction Period: (Baseline - Week 16): Participants received two SC injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection Q2W from Week 4 until Week 14.	Induction - Lebrikizumab 250 mg Q4W n=59 Participants Induction Period (Baseline - Week 16): Participants received 500 mg of Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline followed by 250 mg of Lebrikizumab administered SC Q4W from Week 4 until Week 12.	Induction - Lebrikizumab 250 mg Q2W n=80 Participants Induction Period (Baseline - Week 16): Participants received 500 mg of Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 followed by 250 mg of Lebrikizumab administered SC Q2W from Week 4 until Week 14.
Percentage of Participants With an Itch NRS Score of ≥4-points at Baseline Who Achieve A ≥4-point Reduction From Baseline to Week 16	3.3 Percentage of participants Interval 0.0 to 7.9	23.8 Percentage of participants Interval 12.9 to 34.7	32.7 Percentage of participants Interval 22.4 to 43.0

Adverse Events

Induction - Placebo

Serious events: 2 serious events

Other events: 52 other events

Deaths: 0 deaths

Induction - Lebrikizumab 250mg Q4W

Serious events: 0 serious events

Other events: 49 other events

Deaths: 0 deaths

Induction - Lebrikizumab 250mg Q2W

Serious events: 1 serious events

Other events: 93 other events

Deaths: 0 deaths

Maintenance Blinded Period - Lebrikizumab Q4W Responder/Lebrikizumab Q4W

Serious events: 1 serious events

Other events: 31 other events

Deaths: 0 deaths

Maintenance Blinded Period - Lebrikizumab Q2W Responder/ Lebrikizumab Q4W

Serious events: 0 serious events

Other events: 25 other events

Deaths: 0 deaths

Maintenance Blinded Period - Lebrikizumab Q2W Responder/Lebrikizumab Q2W

Serious events: 1 serious events

Other events: 29 other events

Deaths: 0 deaths

Maintenance Blinded Period - Placebo Responder/Placebo

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Escape Arm Week 16 - Maintenance Open Label - Placebo Non Responder/Lebrikizumab 250 mg Q2W

Serious events: 1 serious events

Other events: 63 other events

Deaths: 0 deaths

Escape Arm Week 16 Maintenance Open Label-Lebrikizumab 250mg Q4W Nonresponder/Lebrikizumab 250mg Q2W

Serious events: 2 serious events

Other events: 36 other events

Deaths: 0 deaths

Escape Arm Week 16 Maintenance Open Label-Lebrikizumab 250mg Q2W Nonresponder/Lebrikizumab 250mg Q2W

Serious events: 1 serious events

Other events: 49 other events

Deaths: 0 deaths

Escape Arm Week 20 to 64 Maintenance Open Label Lebrikizumab 250 Q2W

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Measure	Induction - Placebo n=82 participants at risk Induction Period: (Baseline - Week 16): Participants received two SC injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection Q2W from Week 4 until Week 14.	Induction - Lebrikizumab 250mg Q4W n=81 participants at risk Induction Period (Baseline - Week 16): Participants received 500 mg of Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and followed by 250 mg of Lebrikizumab administered SC Q4W from Week 4 until Week 12.	Induction - Lebrikizumab 250mg Q2W n=123 participants at risk Induction Period (Baseline - Week 16): Participants received 500 mg of Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 followed by 250 mg of Lebrikizumab administered SC Q2W from Week 4 until Week 14.	Maintenance Blinded Period - Lebrikizumab Q4W Responder/Lebrikizumab Q4W n=38 participants at risk Maintenance Primary Population: Maintenance Period (Week 16 - Week 68): Participants received 250 mg Lebrikizumab administered SC Q4W from Weeks 16 until Week 64.	Maintenance Blinded Period - Lebrikizumab Q2W Responder/ Lebrikizumab Q4W n=33 participants at risk Maintenance Primary Population: Maintenance Period (Week 16 - Week 68): Participants received 250 mg Lebrikizumab administered SC Q4W from Week 16 until Week 64.	Maintenance Blinded Period - Lebrikizumab Q2W Responder/Lebrikizumab Q2W n=32 participants at risk Maintenance Period (Week 16 - Week 68): Participants received 250 mg of Lebrikizumab administered SC Q2W from Week 16 until Week 66.	Maintenance Blinded Period - Placebo Responder/Placebo n=11 participants at risk Maintenance Secondary Population: Maintenance Period (Week 16 - Week 68): Participants received Placebo administered SC Q2W from Week 16 to Week 66.	Escape Arm Week 16 - Maintenance Open Label - Placebo Non Responder/Lebrikizumab 250 mg Q2W n=71 participants at risk Participants received blinded doses based on prior treatment assignment followed by one 250 mg Lebrikizumab administered SC Q2W until Week 68 in an open-label fashion. For participants who received placebo in the Induction Period, loading dose was: Two 250 mg Lebrikizumab SC injection on Week 16 and two 250 mg Lebrikizumab SC injections on Week 18. For participants who did not maintain an acceptable response during the Maintenance Period and entered the Escape Arm, the loading doses were administrated at entry and 2 weeks after entry based on the treatment assignment prior to entering escape arm.	Escape Arm Week 16 Maintenance Open Label-Lebrikizumab 250mg Q4W Nonresponder/Lebrikizumab 250mg Q2W n=42 participants at risk Participants received blinded doses based on prior treatment assignment followed by one 250 mg Lebrikizumab administered SC Q2W until Week 68 in an open-label fashion. For participants who received Lebrikizumab Q4W in the Induction Period, the loading dose was: One 250 mg Lebrikizumab administered SC on Week16 and Week 18. For participants who did not maintain an acceptable response during the Maintenance Period and entered the Escape Arm, the loading doses were administrated at entry and 2 weeks after entry based on the treatment assignment prior to entering escape arm.	Escape Arm Week 16 Maintenance Open Label-Lebrikizumab 250mg Q2W Nonresponder/Lebrikizumab 250mg Q2W n=55 participants at risk Participants received blinded doses based on prior treatment assignment followed by one 250 mg Lebrikizumab administered SC Q2W until Week 68 in an open-label fashion. For participants who received Lebrikizumab Q2W in the Induction Period, the loading dose was: One 250 mg Lebrikizumab administered SC on Week16 and Week 18. For participants who did not maintain an acceptable response during the Maintenance Period and entered the Escape Arm, the loading doses were administrated at entry and 2 weeks after entry based on the treatment assignment prior to entering escape arm.	Escape Arm Week 20 to 64 Maintenance Open Label Lebrikizumab 250 Q2W n=8 participants at risk Participants received 250 mg Lebrikizumab administered SC Q2W through Week 68 in an open-label fashion.
Injury, poisoning and procedural complications Ligament injury	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.1% 1/32 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hodgkin's disease	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Immune system disorders Anaphylactic reaction	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.6% 1/38 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Appendicitis	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	12.5% 1/8 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Campylobacter gastroenteritis	1.2% 1/82 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Covid-19	1.2% 1/82 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.4% 1/71 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Tonsillitis	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.8% 1/55 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Cerebral infarction	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.81% 1/123 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Reproductive system and breast disorders Ovarian cyst	0.00% 0/24 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/41 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/9 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Dermatitis atopic	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Surgical and medical procedures Tonsillectomy	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Surgical and medical procedures Tooth extraction	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.

Other adverse events

Measure	Induction - Placebo n=82 participants at risk Induction Period: (Baseline - Week 16): Participants received two SC injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection Q2W from Week 4 until Week 14.	Induction - Lebrikizumab 250mg Q4W n=81 participants at risk Induction Period (Baseline - Week 16): Participants received 500 mg of Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and followed by 250 mg of Lebrikizumab administered SC Q4W from Week 4 until Week 12.	Induction - Lebrikizumab 250mg Q2W n=123 participants at risk Induction Period (Baseline - Week 16): Participants received 500 mg of Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 followed by 250 mg of Lebrikizumab administered SC Q2W from Week 4 until Week 14.	Maintenance Blinded Period - Lebrikizumab Q4W Responder/Lebrikizumab Q4W n=38 participants at risk Maintenance Primary Population: Maintenance Period (Week 16 - Week 68): Participants received 250 mg Lebrikizumab administered SC Q4W from Weeks 16 until Week 64.	Maintenance Blinded Period - Lebrikizumab Q2W Responder/ Lebrikizumab Q4W n=33 participants at risk Maintenance Primary Population: Maintenance Period (Week 16 - Week 68): Participants received 250 mg Lebrikizumab administered SC Q4W from Week 16 until Week 64.	Maintenance Blinded Period - Lebrikizumab Q2W Responder/Lebrikizumab Q2W n=32 participants at risk Maintenance Period (Week 16 - Week 68): Participants received 250 mg of Lebrikizumab administered SC Q2W from Week 16 until Week 66.	Maintenance Blinded Period - Placebo Responder/Placebo n=11 participants at risk Maintenance Secondary Population: Maintenance Period (Week 16 - Week 68): Participants received Placebo administered SC Q2W from Week 16 to Week 66.	Escape Arm Week 16 - Maintenance Open Label - Placebo Non Responder/Lebrikizumab 250 mg Q2W n=71 participants at risk Participants received blinded doses based on prior treatment assignment followed by one 250 mg Lebrikizumab administered SC Q2W until Week 68 in an open-label fashion. For participants who received placebo in the Induction Period, loading dose was: Two 250 mg Lebrikizumab SC injection on Week 16 and two 250 mg Lebrikizumab SC injections on Week 18. For participants who did not maintain an acceptable response during the Maintenance Period and entered the Escape Arm, the loading doses were administrated at entry and 2 weeks after entry based on the treatment assignment prior to entering escape arm.	Escape Arm Week 16 Maintenance Open Label-Lebrikizumab 250mg Q4W Nonresponder/Lebrikizumab 250mg Q2W n=42 participants at risk Participants received blinded doses based on prior treatment assignment followed by one 250 mg Lebrikizumab administered SC Q2W until Week 68 in an open-label fashion. For participants who received Lebrikizumab Q4W in the Induction Period, the loading dose was: One 250 mg Lebrikizumab administered SC on Week16 and Week 18. For participants who did not maintain an acceptable response during the Maintenance Period and entered the Escape Arm, the loading doses were administrated at entry and 2 weeks after entry based on the treatment assignment prior to entering escape arm.	Escape Arm Week 16 Maintenance Open Label-Lebrikizumab 250mg Q2W Nonresponder/Lebrikizumab 250mg Q2W n=55 participants at risk Participants received blinded doses based on prior treatment assignment followed by one 250 mg Lebrikizumab administered SC Q2W until Week 68 in an open-label fashion. For participants who received Lebrikizumab Q2W in the Induction Period, the loading dose was: One 250 mg Lebrikizumab administered SC on Week16 and Week 18. For participants who did not maintain an acceptable response during the Maintenance Period and entered the Escape Arm, the loading doses were administrated at entry and 2 weeks after entry based on the treatment assignment prior to entering escape arm.	Escape Arm Week 20 to 64 Maintenance Open Label Lebrikizumab 250 Q2W n=8 participants at risk Participants received 250 mg Lebrikizumab administered SC Q2W through Week 68 in an open-label fashion.
Gastrointestinal disorders Stomatitis	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.81% 1/123 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Upper respiratory tract infection	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.6% 2/123 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.6% 1/38 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.1% 1/32 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	9.1% 1/11 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	4.2% 3/71 • Number of events 4 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Large intestine polyp	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Nausea	1.2% 1/82 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Oesophagitis	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Blood and lymphatic system disorders Anaemia	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.8% 1/55 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Blood and lymphatic system disorders Leukopenia	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.81% 1/123 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.1% 1/32 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Blood and lymphatic system disorders Lymphadenitis	1.2% 1/82 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Blood and lymphatic system disorders Lymphadenopathy	1.2% 1/82 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.81% 1/123 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Blood and lymphatic system disorders White blood cell disorder	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.1% 1/32 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Arrhythmia	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Ear and labyrinth disorders Otorrhoea	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.81% 1/123 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Ear and labyrinth disorders Tinnitus	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.6% 1/38 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Ear and labyrinth disorders Vertigo positional	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.1% 1/32 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.4% 1/71 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Asthenopia	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.81% 1/123 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.8% 1/55 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Blepharitis	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.6% 2/123 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.8% 2/71 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Blepharitis allergic	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Cataract	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	9.1% 1/11 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Central serous chorioretinopathy	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Chalazion	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.81% 1/123 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.0% 1/33 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.1% 1/32 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Conjunctival haemorrhage	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Conjunctival hyperaemia	1.2% 1/82 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Conjunctivitis allergic	4.9% 4/82 • Number of events 4 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	12.3% 10/81 • Number of events 11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	17.1% 21/123 • Number of events 23 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	13.2% 5/38 • Number of events 6 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.0% 1/33 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	12.5% 4/32 • Number of events 4 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	18.3% 13/71 • Number of events 14 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	5.5% 3/55 • Number of events 3 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Dry eye	2.4% 2/82 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.6% 2/123 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.4% 1/71 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.6% 2/55 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Eye opacity	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.81% 1/123 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Eye paraesthesia	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.8% 1/55 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Eye pruritus	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 3/123 • Number of events 3 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.1% 1/32 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.4% 1/71 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.8% 1/55 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Giant papillary conjunctivitis	1.2% 1/82 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Glaucoma	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.8% 1/55 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Keratitis	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.8% 1/55 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Macular oedema	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Pingueculitis	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.81% 1/123 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Punctate keratitis	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.4% 1/71 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Retinal haemorrhage	1.2% 1/82 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Retinal tear	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.81% 1/123 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Vitreous floaters	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Abdominal discomfort	1.2% 1/82 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.81% 1/123 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.0% 1/33 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Abdominal pain	1.2% 1/82 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.81% 1/123 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.6% 1/38 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	12.5% 1/8 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.81% 1/123 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.0% 1/33 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.8% 2/71 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Acute abdomen	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.6% 1/38 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Aphthous ulcer	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Colitis	1.2% 1/82 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Colitis ischaemic	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Constipation	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.6% 2/123 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.1% 1/32 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Dental caries	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.6% 2/123 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	7.9% 3/38 • Number of events 3 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	9.1% 3/33 • Number of events 3 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	9.4% 3/32 • Number of events 3 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	7.0% 5/71 • Number of events 5 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	4.8% 2/42 • Number of events 3 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.6% 2/55 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Diarrhoea	2.4% 2/82 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.5% 2/81 • Number of events 3 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.6% 2/123 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.6% 1/38 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	6.1% 2/33 • Number of events 7 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.1% 1/32 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.4% 1/71 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.8% 1/55 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	12.5% 1/8 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Dry mouth	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.0% 1/33 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Dyspepsia	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.6% 1/38 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Enterocolitis	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.6% 1/38 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.4% 1/71 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Haemorrhoids	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.81% 1/123 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.0% 1/33 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Hypoaesthesia oral	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.8% 1/55 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Toothache	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.4% 1/71 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.8% 1/55 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Vomiting	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Administration site erythema	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.4% 1/71 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Axillary pain	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.0% 1/33 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Catheter site pruritus	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.4% 1/71 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Chest pain	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.81% 1/123 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Fatigue	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.6% 1/38 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.8% 1/55 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Infusion site bruising	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.4% 1/71 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Injection site erythema	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.6% 2/123 • Number of events 3 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.6% 1/38 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.0% 1/33 • Number of events 3 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	9.4% 3/32 • Number of events 34 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.8% 2/71 • Number of events 9 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Injection site haematoma	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.4% 1/71 • Number of events 4 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Injection site pain	2.4% 2/82 • Number of events 3 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.81% 1/123 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.4% 1/71 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Injection site paraesthesia	1.2% 1/82 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Injection site pruritus	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.6% 2/123 • Number of events 3 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.6% 1/38 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.1% 1/32 • Number of events 13 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Injection site reaction	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 3/123 • Number of events 11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	6.1% 2/33 • Number of events 14 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.4% 1/71 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.6% 2/55 • Number of events 29 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Injection site swelling	1.2% 1/82 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.81% 1/123 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Malaise	2.4% 2/82 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.3% 4/123 • Number of events 5 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.6% 1/38 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.0% 1/33 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	7.1% 3/42 • Number of events 3 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Oedema peripheral	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.81% 1/123 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Pain	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.81% 1/123 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Pyrexia	15.9% 13/82 • Number of events 15 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	18.5% 15/81 • Number of events 18 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	20.3% 25/123 • Number of events 32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	18.4% 7/38 • Number of events 11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	18.2% 6/33 • Number of events 6 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	34.4% 11/32 • Number of events 15 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	27.3% 3/11 • Number of events 3 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	18.3% 13/71 • Number of events 14 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	9.5% 4/42 • Number of events 5 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	9.1% 5/55 • Number of events 5 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Swelling	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.81% 1/123 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Vaccination site pain	4.9% 4/82 • Number of events 4 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.7% 3/81 • Number of events 3 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.3% 4/123 • Number of events 4 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.4% 1/71 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.8% 1/55 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Vaccination site reaction	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.81% 1/123 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.4% 1/71 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Hepatobiliary disorders Hepatic steatosis	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	12.5% 1/8 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.4% 1/71 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Hepatobiliary disorders Liver disorder	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.8% 1/55 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Immune system disorders Contrast media allergy	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Immune system disorders Food allergy	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.6% 1/38 • Number of events 3 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Immune system disorders Immunisation reaction	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.81% 1/123 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.6% 1/38 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	6.2% 2/32 • Number of events 3 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	9.1% 1/11 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.4% 1/71 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Immune system disorders Seasonal allergy	1.2% 1/82 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Acne pustular	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.6% 1/38 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Bartholinitis	0.00% 0/24 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/41 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/9 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Body tinea	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.81% 1/123 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	9.1% 1/11 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.8% 1/55 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Bronchitis	1.2% 1/82 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.81% 1/123 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	6.1% 2/33 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.8% 1/55 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Campylobacter gastroenteritis	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Cellulitis	3.7% 3/82 • Number of events 3 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.4% 1/71 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.8% 1/55 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Conjunctivitis	2.4% 2/82 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	6.2% 5/81 • Number of events 5 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	9.8% 12/123 • Number of events 13 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	9.1% 1/11 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	14.1% 10/71 • Number of events 13 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.8% 1/55 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Conjunctivitis bacterial	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.5% 2/81 • Number of events 3 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	4.8% 2/42 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.8% 1/55 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Covid-19	2.4% 2/82 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.5% 2/81 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.81% 1/123 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	18.4% 7/38 • Number of events 7 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	21.2% 7/33 • Number of events 8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	12.5% 4/32 • Number of events 4 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	18.3% 13/71 • Number of events 13 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	19.0% 8/42 • Number of events 8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	21.8% 12/55 • Number of events 13 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	25.0% 2/8 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Cystitis	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.6% 2/55 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Dermatophytosis of nail	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.6% 1/38 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.1% 1/32 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Eczema herpeticum	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.0% 1/33 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.4% 1/71 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Erysipelas	1.2% 1/82 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Folliculitis	9.8% 8/82 • Number of events 8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	6.2% 5/81 • Number of events 5 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	5.7% 7/123 • Number of events 7 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	7.9% 3/38 • Number of events 4 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.0% 1/33 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.1% 1/32 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	8.5% 6/71 • Number of events 6 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	4.8% 2/42 • Number of events 6 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	9.1% 5/55 • Number of events 6 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	12.5% 1/8 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Furuncle	1.2% 1/82 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.81% 1/123 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.0% 1/33 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.1% 1/32 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	9.1% 1/11 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	4.2% 3/71 • Number of events 4 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.8% 1/55 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	12.5% 1/8 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Gastroenteritis	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.81% 1/123 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.6% 1/38 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.4% 1/71 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.8% 1/55 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Gastroenteritis bacterial	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Gastroenteritis viral	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.1% 1/32 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Gingivitis	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.81% 1/123 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.6% 1/38 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	6.1% 2/33 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Hand-foot-and-mouth disease	1.2% 1/82 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Herpes ophthalmic	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Herpes simplex	2.4% 2/82 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.81% 1/123 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	7.9% 3/38 • Number of events 6 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	9.1% 3/33 • Number of events 10 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.1% 1/32 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.8% 2/71 • Number of events 3 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	19.0% 8/42 • Number of events 11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.6% 2/55 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Herpes zoster	1.2% 1/82 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.6% 1/38 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	4.2% 3/71 • Number of events 3 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.6% 2/55 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Hordeolum	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.4% 1/71 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.8% 1/55 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	12.5% 1/8 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Impetigo	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.2% 1/81 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Infected dermal cyst	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.81% 1/123 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.8% 1/55 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Infection	1.2% 1/82 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Influenza	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Keratitis bacterial	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.4% 1/71 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Malassezia infection	2.4% 2/82 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.81% 1/123 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.8% 2/71 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Molluscum contagiosum	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.81% 1/123 • Number of events 3 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.1% 1/32 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	4.8% 2/42 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.8% 1/55 • Number of events 4 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Nasopharyngitis	2.4% 2/82 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	6.2% 5/81 • Number of events 5 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	5.7% 7/123 • Number of events 8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 2/38 • Number of events 4 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	6.1% 2/33 • Number of events 3 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	9.4% 3/32 • Number of events 3 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	9.1% 1/11 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	11.3% 8/71 • Number of events 8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	14.3% 6/42 • Number of events 7 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	12.7% 7/55 • Number of events 8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	12.5% 1/8 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Omphalitis	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.4% 1/71 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Ophthalmic herpes simplex	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Oral candidiasis	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.81% 1/123 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Oral herpes	2.4% 2/82 • Number of events 3 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.5% 2/81 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	4.9% 6/123 • Number of events 6 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	7.9% 3/38 • Number of events 4 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.1% 1/32 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.8% 2/71 • Number of events 3 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.6% 2/55 • Number of events 3 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Otitis externa	3.7% 3/82 • Number of events 3 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Paronychia	1.2% 1/82 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.1% 1/32 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.8% 1/55 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Parotitis	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Pericoronitis	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.6% 2/123 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.0% 1/33 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Periodontitis	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.1% 1/32 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	9.1% 1/11 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.8% 2/71 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	12.5% 1/8 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Peritonsillar abscess	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.8% 1/55 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Pharyngitis	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.6% 1/38 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	6.1% 2/33 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.4% 1/71 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Pilonidal disease	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.0% 1/33 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Pulpitis dental	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.1% 1/32 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Respiratory tract infection	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.8% 1/55 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Rhinitis	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.4% 1/71 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Sinusitis	1.2% 1/82 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.6% 2/123 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	4.8% 2/42 • Number of events 4 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Skin bacterial infection	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Skin candida	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.6% 1/38 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Skin infection	2.4% 2/82 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.81% 1/123 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.4% 1/71 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.8% 1/55 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Subcutaneous abscess	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.8% 1/55 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Tinea infection	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.6% 1/38 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Tinea pedis	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.81% 1/123 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.1% 1/32 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	9.1% 1/11 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Tonsillitis	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Urinary tract infection	1.2% 1/82 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.0% 1/33 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.4% 1/71 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Urogenital infection bacterial	1.2% 1/82 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Vestibulitis	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.6% 1/38 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Vulvovaginal candidiasis	4.2% 1/24 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/41 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/9 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Wound infection	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.81% 1/123 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Animal bite	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.6% 2/55 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.0% 1/33 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Arthropod sting	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.8% 2/71 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Avulsion fracture	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.4% 1/71 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Bone fissure	1.2% 1/82 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Contusion	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.1% 1/32 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Dental restoration failure	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.8% 1/55 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Epicondylitis	1.2% 1/82 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Fibula fracture	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.6% 1/38 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Forearm fracture	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.0% 1/33 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Hand fracture	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.4% 1/71 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.8% 1/55 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Heat illness	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.1% 1/32 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.1% 1/32 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Ligament injury	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.6% 1/38 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.4% 1/71 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Ligament sprain	2.4% 2/82 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.6% 1/38 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	6.1% 2/33 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	4.2% 3/71 • Number of events 3 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Limb injury	1.2% 1/82 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Muscle strain	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.1% 1/32 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Post vaccination syndrome	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.81% 1/123 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 2/38 • Number of events 3 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.0% 1/33 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	4.2% 3/71 • Number of events 3 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	4.8% 2/42 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.8% 1/55 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.81% 1/123 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.1% 1/32 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Scratch	1.2% 1/82 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Skin abrasion	2.4% 2/82 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.81% 1/123 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.1% 1/32 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.4% 1/71 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Skin laceration	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.0% 1/33 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Spinal fracture	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Stab wound	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.1% 1/32 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.8% 1/55 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Sunburn	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Thermal burn	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.81% 1/123 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.0% 1/33 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.4% 1/71 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Ulna fracture	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.6% 1/38 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Vaccination complication	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.81% 1/123 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.8% 1/55 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Wound	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.81% 1/123 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.6% 1/38 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Wrist fracture	1.2% 1/82 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Alanine aminotransferase increased	2.4% 2/82 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Aspartate aminotransferase increased	2.4% 2/82 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Blood creatine phosphokinase increased	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.1% 1/32 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Blood triglycerides increased	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.4% 1/71 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.8% 1/55 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Blood uric acid increased	1.2% 1/82 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Fibrin d dimer increased	1.2% 1/82 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Fluoride increased	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.4% 1/71 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Helicobacter test positive	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.81% 1/123 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	9.1% 1/11 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Hepatic enzyme increased	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Hormone level abnormal	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.81% 1/123 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Liver function test increased	1.2% 1/82 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.0% 1/33 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Neutrophil count abnormal	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.1% 1/32 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Neutrophil count decreased	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	4.8% 2/42 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Platelet count increased	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.81% 1/123 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations White blood cell count decreased	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations White blood cell count increased	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.81% 1/123 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Decreased appetite	1.2% 1/82 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Dehydration	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Dyslipidaemia	2.4% 2/82 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.81% 1/123 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Gout	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.4% 1/71 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Hypercholesterolaemia	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.81% 1/123 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.8% 1/55 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.81% 1/123 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.4% 1/71 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Hyperlipidaemia	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.6% 1/38 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.4% 1/71 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.6% 1/38 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.5% 2/81 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Metabolic disorder	1.2% 1/82 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.4% 1/71 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 3/123 • Number of events 3 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	6.1% 2/33 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.8% 2/71 • Number of events 3 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.5% 2/81 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.6% 2/123 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.6% 1/38 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.0% 1/33 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	6.2% 2/32 • Number of events 3 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	11.3% 8/71 • Number of events 8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	4.8% 2/42 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	7.3% 4/55 • Number of events 4 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Chondrocalcinosis	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.4% 1/71 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	1.2% 1/82 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	9.1% 1/11 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Joint swelling	1.2% 1/82 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.0% 1/33 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.81% 1/123 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	1.2% 1/82 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.6% 1/38 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.2% 1/81 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	4.1% 5/123 • Number of events 8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.6% 1/38 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.0% 1/33 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.1% 1/32 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.4% 1/71 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	7.1% 3/42 • Number of events 4 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.6% 2/55 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Neck pain	1.2% 1/82 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.3% 4/123 • Number of events 4 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.6% 1/38 • Number of events 3 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.0% 1/33 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.1% 1/32 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	4.2% 3/71 • Number of events 6 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.8% 1/55 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Pain in jaw	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.1% 1/32 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Periarthritis	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.8% 1/55 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Tendonitis	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.1% 1/32 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Tenosynovitis	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.6% 1/38 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	6.1% 2/33 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.1% 1/32 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.6% 2/55 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Trigger finger	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.81% 1/123 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acrochordon	1.2% 1/82 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anogenital warts	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oral fibroma	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.1% 1/32 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Seborrhoeic keratosis	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 3/123 • Number of events 3 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 2/38 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.0% 1/33 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.1% 1/32 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	18.2% 2/11 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	4.2% 3/71 • Number of events 5 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	9.5% 4/42 • Number of events 4 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.8% 1/55 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Autonomic nervous system imbalance	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.0% 1/33 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Carpal tunnel syndrome	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Cervicobrachial syndrome	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.1% 1/32 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.4% 1/71 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Dizziness	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.6% 1/38 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.4% 1/71 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.8% 1/55 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Dysgeusia	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.81% 1/123 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Dyslalia	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.81% 1/123 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Headache	11.0% 9/82 • Number of events 16 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.7% 3/81 • Number of events 4 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.3% 4/123 • Number of events 7 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.6% 1/38 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	18.2% 6/33 • Number of events 16 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	12.5% 4/32 • Number of events 4 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	9.1% 1/11 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	5.6% 4/71 • Number of events 17 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	4.8% 2/42 • Number of events 3 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.6% 2/55 • Number of events 4 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	12.5% 1/8 • Number of events 5 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Loss of consciousness	1.2% 1/82 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Menstrual headache	4.2% 1/24 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/41 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 1/19 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/9 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Migraine	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.0% 1/33 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Neuralgia	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.1% 1/32 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Parosmia	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Presyncope	1.2% 1/82 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Radiculopathy	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Somnolence	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.1% 1/32 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Syncope	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.81% 1/123 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Pregnancy, puerperium and perinatal conditions Hyperemesis gravidarum	0.00% 0/24 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/41 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/9 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Anxiety	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.6% 1/38 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Attention deficit hyperactivity disorder	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.6% 1/38 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Bipolar disorder	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.8% 1/55 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Dysphoria	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.81% 1/123 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Insomnia	1.2% 1/82 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.1% 1/32 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	9.1% 1/11 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	4.8% 2/42 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Mixed anxiety and depressive disorder	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	9.1% 1/11 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Sleep disorder	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.1% 1/32 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Nephrolithiasis	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.4% 1/71 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Reproductive system and breast disorders Dysmenorrhoea	0.00% 0/24 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	4.9% 2/41 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	16.7% 2/12 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	8.3% 1/12 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.5% 2/19 • Number of events 7 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/9 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Reproductive system and breast disorders Endometriosis	0.00% 0/24 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/41 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/9 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Reproductive system and breast disorders Menstruation irregular	4.2% 1/24 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/41 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/9 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Reproductive system and breast disorders Ovarian cyst	0.00% 0/24 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/25 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/41 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/9 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 1/15 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.6% 2/123 • Number of events 3 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.1% 1/32 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.8% 2/71 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.81% 1/123 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Laryngeal oedema	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.6% 1/38 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Oropharyngeal discomfort	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.8% 1/55 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.6% 2/123 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.8% 1/55 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Respiratory tract inflammation	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.8% 1/55 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 3/123 • Number of events 3 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.1% 1/32 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	4.2% 3/71 • Number of events 3 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.81% 1/123 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.0% 1/33 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	18.2% 2/11 • Number of events 3 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.4% 1/71 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.4% 1/71 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Upper respiratory tract inflammation	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.6% 1/38 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Vocal cord inflammation	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.81% 1/123 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Acne	6.1% 5/82 • Number of events 5 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.5% 2/81 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.3% 4/123 • Number of events 4 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.6% 1/38 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	18.2% 6/33 • Number of events 6 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	9.4% 3/32 • Number of events 3 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	9.1% 1/11 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	7.0% 5/71 • Number of events 6 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	7.1% 3/42 • Number of events 3 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	10.9% 6/55 • Number of events 8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	12.5% 1/8 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Alopecia areata	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Chloasma	0.00% 0/24 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	4.0% 1/25 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/41 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/12 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/5 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/19 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/9 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/15 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/3 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Dermal cyst	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.6% 1/38 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.8% 2/71 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.8% 1/55 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Dermatitis atopic	2.4% 2/82 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.8% 1/55 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 3/123 • Number of events 3 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.0% 1/33 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	9.1% 1/11 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.4% 1/71 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Dermatitis psoriasiform	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.8% 1/55 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Dyshidrotic eczema	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.5% 2/81 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Eczema asteatotic	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.1% 1/32 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	9.1% 1/11 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.6% 1/38 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.0% 1/33 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.8% 2/71 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Hand dermatitis	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.4% 1/71 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Hyperkeratosis	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.6% 1/38 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.1% 1/32 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.8% 2/71 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Ingrowing nail	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.1% 1/32 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Keratosis pilaris	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Milia	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.81% 1/123 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.6% 1/38 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.1% 1/32 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	4.2% 3/71 • Number of events 3 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Miliaria	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	12.5% 1/8 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Needle track marks	1.2% 1/82 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Prurigo	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.8% 1/55 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Rosacea	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.4% 1/71 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.8% 1/55 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Seborrhoeic dermatitis	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.8% 2/71 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Skin erosion	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Telangiectasia	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.0% 1/33 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Urticaria	2.4% 2/82 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.5% 2/81 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.8% 2/71 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	4.8% 2/42 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.8% 1/55 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Surgical and medical procedures Anal fistula repair	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.2% 1/81 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Surgical and medical procedures Cataract operation	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	9.1% 1/11 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Surgical and medical procedures Dental care	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.4% 1/71 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Surgical and medical procedures Dental implantation	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.8% 1/55 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Surgical and medical procedures Intraocular lens implant	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.8% 1/55 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Surgical and medical procedures Skin lesion removal	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.81% 1/123 • Number of events 3 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.8% 1/55 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Surgical and medical procedures Skin operation	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.8% 1/55 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Surgical and medical procedures Tooth extraction	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.6% 2/123 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 2/38 • Number of events 2 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.4% 1/71 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.4% 1/42 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.8% 1/55 • Number of events 3 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	12.5% 1/8 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Surgical and medical procedures Tooth restoration	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.6% 1/38 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Surgical and medical procedures Wisdom teeth removal	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.81% 1/123 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.0% 1/33 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Arteriosclerosis	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.1% 1/32 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.8% 1/55 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Hypertension	1.2% 1/82 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.6% 1/38 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/71 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Internal haemorrhage	0.00% 0/82 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/81 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/123 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/38 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/33 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/32 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/11 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.4% 1/71 • Number of events 1 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/42 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/55 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/8 • Baseline Up To Week 68. All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Email: ClinicalTrials.gov@lilly.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60