Trial Outcomes & Findings for Chronic Pain Master Protocol (CPMP): A Study of LY3526318 in Participants With Chronic Low Back Pain (NCT NCT05086289)

NCT ID: NCT05086289

Last Updated: 2023-10-05

Results Overview

The NRS was used to describe pain severity. Participants were asked to describe their average pain over the past 24 hours, on a scale of 0 to 10: 0 = no pain, and 10 = pain as bad as you can imagine. Posterior mean change from baseline, 95 percent (%) credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 159 participants
• Primary outcome timeframe: Baseline, Week 4
• Results posted on: 2023-10-05

Participant Flow

Participant milestones

Measure	250 Milligram (mg) LY3526318 Participants received 250 mg of LY3526318 orally, once daily for the first 4 weeks of treatment period and were switched to placebo once daily for the next 4 weeks of the treatment period.	Placebo Participants received placebo orally, once daily, for 8-weeks treatment period.
Overall Study STARTED	105	54
Overall Study Received at Least One Dose of Study Drug (Safety Population Week 1-4)	105	54
Overall Study Safety Population Week 5-8	92	50
Overall Study COMPLETED	90	49
Overall Study NOT COMPLETED	15	5

Reasons for withdrawal

Measure	250 Milligram (mg) LY3526318 Participants received 250 mg of LY3526318 orally, once daily for the first 4 weeks of treatment period and were switched to placebo once daily for the next 4 weeks of the treatment period.	Placebo Participants received placebo orally, once daily, for 8-weeks treatment period.
Overall Study Adverse Event	4	2
Overall Study Lost to Follow-up	2	0
Overall Study Non-compliance with study drug	2	1
Overall Study Physician Decision	2	0
Overall Study Withdrawal by Subject	5	2

Baseline Characteristics

Chronic Pain Master Protocol (CPMP): A Study of LY3526318 in Participants With Chronic Low Back Pain

Baseline characteristics by cohort

Measure	250 mg LY3526318 n=105 Participants Participants received 250 mg of LY3526318 orally, once daily for the first 4 weeks of treatment period and were switched to placebo once daily for the next 4 weeks of the treatment period.	Placebo n=54 Participants Participants received placebo orally, once daily, for 8-weeks treatment period.	Total n=159 Participants Total of all reporting groups
Age, Continuous	54.00 years STANDARD_DEVIATION 13.20 • n=5 Participants	54.30 years STANDARD_DEVIATION 13.74 • n=7 Participants	54.10 years STANDARD_DEVIATION 13.34 • n=5 Participants
Sex: Female, Male Female	66 Participants n=5 Participants	35 Participants n=7 Participants	101 Participants n=5 Participants
Sex: Female, Male Male	39 Participants n=5 Participants	19 Participants n=7 Participants	58 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	25 Participants n=5 Participants	15 Participants n=7 Participants	40 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	80 Participants n=5 Participants	39 Participants n=7 Participants	119 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	14 Participants n=5 Participants	6 Participants n=7 Participants	20 Participants n=5 Participants
Race (NIH/OMB) White	84 Participants n=5 Participants	42 Participants n=7 Participants	126 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment Puerto Rico	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	103 Participants n=5 Participants	52 Participants n=7 Participants	155 Participants n=5 Participants
Average Pain Intensity as Measured by the Numeric Rating Scale (NRS)	5.56 score on a scale STANDARD_DEVIATION 1.57 • n=5 Participants	5.79 score on a scale STANDARD_DEVIATION 1.54 • n=7 Participants	5.64 score on a scale STANDARD_DEVIATION 1.56 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 4

Population: All enrolled participants who received at least one dose of study drug. Here, the overall number of participants analyzed includes the number of participants with non-missing value at Week 4.

The NRS was used to describe pain severity. Participants were asked to describe their average pain over the past 24 hours, on a scale of 0 to 10: 0 = no pain, and 10 = pain as bad as you can imagine.

Posterior mean change from baseline, 95 percent (%) credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.

Outcome measures

Measure	250 mg LY3526318 n=92 Participants Participants received 250 mg of LY3526318 orally, once daily for the first 4 weeks of treatment period and were switched to placebo once daily for the next 4 weeks of the treatment period.	Placebo n=50 Participants Participants received placebo orally, once daily, for 8-weeks treatment period.
Change From Baseline for Average Pain Intensity as Measured by the Numeric Rating Scale (NRS) at Week 4	-1.28 score on a scale Interval -1.59 to -0.97	-0.90 score on a scale Interval -1.32 to -0.48

SECONDARY outcome

Timeframe: Baseline, Week 8

Population: All enrolled participants who received at least one dose of study drug. Here, the overall number of participants analyzed includes the number of participants with non-missing value at Week 8.

The NRS was used to describe pain severity. Participants were asked to describe their average pain over the past 24 hours, on a scale of 0 to 10: 0 = no pain, and 10 = pain as bad as you can imagine.

Posterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.

Outcome measures

Measure	250 mg LY3526318 n=87 Participants Participants received 250 mg of LY3526318 orally, once daily for the first 4 weeks of treatment period and were switched to placebo once daily for the next 4 weeks of the treatment period.	Placebo n=47 Participants Participants received placebo orally, once daily, for 8-weeks treatment period.
Change From Baseline for Average Pain Intensity as Measured by the Numeric Rating Scale (NRS)	-1.47 score on a scale Interval -1.82 to -1.12	-1.20 score on a scale Interval -1.67 to -0.73

SECONDARY outcome

Timeframe: Baseline, Week 4

Population: All enrolled who received at least one dose of study drug. Here, the overall number of participants analyzed includes the number of participants with non-missing value at Week 4.

The RMDQ is a simple, sensitive, and reliable method to measure disability in patients with back pain that consists of 24 statements relating to the person's perceptions of back pain and associated disability based on physical ability/activity, sleep/rest, psychosocial, household management, eating, and pain frequency. Participants are asked if they feel the statement is descriptive of their own circumstance on that day. The total score is obtained by counting the number of ''Yes'' responses, ranging from: 0 = no disability to 24 = maximal disability.

Posterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.

Outcome measures

Measure	250 mg LY3526318 n=96 Participants Participants received 250 mg of LY3526318 orally, once daily for the first 4 weeks of treatment period and were switched to placebo once daily for the next 4 weeks of the treatment period.	Placebo n=52 Participants Participants received placebo orally, once daily, for 8-weeks treatment period.
Change From Baseline on the Roland Morris Disability Questionnaire (RMDQ)	-2.03 score on a scale Interval -2.82 to -1.25	-1.42 score on a scale Interval -2.49 to -0.36

SECONDARY outcome

Timeframe: Baseline, Week 8

Population: All enrolled who received at least one dose of study drug. Here, the overall number of participants analyzed includes the number of participants with non-missing value at Week 8.

The RMDQ is a simple, sensitive, and reliable method to measure disability in patients with back pain that consists of 24 statements relating to the person's perceptions of back pain and associated disability based on physical ability/activity, sleep/rest, psychosocial, household management, eating, and pain frequency. Participants are asked if they feel the statement is descriptive of their own circumstance on that day. The total score is obtained by counting the number of ''Yes'' responses, ranging from: 0 = no disability to 24 = maximal disability.

Posterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.

Outcome measures

Measure	250 mg LY3526318 n=90 Participants Participants received 250 mg of LY3526318 orally, once daily for the first 4 weeks of treatment period and were switched to placebo once daily for the next 4 weeks of the treatment period.	Placebo n=49 Participants Participants received placebo orally, once daily, for 8-weeks treatment period.
Change From Baseline on the Roland Morris Disability Questionnaire (RMDQ)	-2.55 score on a scale Interval -3.37 to -1.71	-1.37 score on a scale Interval -2.49 to -0.25

SECONDARY outcome

Timeframe: Baseline, Week 4

Population: All enrolled participants who received at least one dose of study drug. Here, the overall number of participants analyzed includes the number of participants with non-missing value at Week 4.

Patients Global Impression of Change captured the participant's perspective of treatment apart from sub-aspects of the general improvement. This is a numeric scale from 1 to 7 where, 1=very much better, and 7=very much worse.

Posterior mean, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.

Outcome measures

Measure	250 mg LY3526318 n=96 Participants Participants received 250 mg of LY3526318 orally, once daily for the first 4 weeks of treatment period and were switched to placebo once daily for the next 4 weeks of the treatment period.	Placebo n=52 Participants Participants received placebo orally, once daily, for 8-weeks treatment period.
Change From Baseline for Overall Improvement as Measured by Patient's Global Impression of Change	3.13 score on a scale Interval 2.94 to 3.31	3.25 score on a scale Interval 2.99 to 3.5

SECONDARY outcome

Timeframe: Baseline, Week 8

Population: All enrolled participants who received at least one dose of study drug. Here, the overall number of participants analyzed includes the number of participants with non-missing value at Week 8.

Patients Global Impression of Change captured the participant's perspective of treatment apart from sub-aspects of the general improvement. This is a numeric scale from 1 to 7: 1 = very much better, and 7 = very much worse.

Posterior mean, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.

Outcome measures

Measure	250 mg LY3526318 n=90 Participants Participants received 250 mg of LY3526318 orally, once daily for the first 4 weeks of treatment period and were switched to placebo once daily for the next 4 weeks of the treatment period.	Placebo n=49 Participants Participants received placebo orally, once daily, for 8-weeks treatment period.
Change From Baseline for Overall Improvement as Measured by Patient's Global Impression of Change	3.00 score on a scale Interval 2.76 to 3.24	3.26 score on a scale Interval 2.93 to 3.59

SECONDARY outcome

Timeframe: Baseline, Week 4

Population: All enrolled participants who received at least one dose of study drug. Here, the overall number of participants analyzed includes the number of participants with non-missing value at Week 4.

The NRS was used to describe pain severity. Participants were asked to describe their worst pain over the past 24 hours, on a scale of 0 to 10: 0=no pain, and 10=pain as bad as you can imagine.

Posterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.

Outcome measures

Measure	250 mg LY3526318 n=92 Participants Participants received 250 mg of LY3526318 orally, once daily for the first 4 weeks of treatment period and were switched to placebo once daily for the next 4 weeks of the treatment period.	Placebo n=50 Participants Participants received placebo orally, once daily, for 8-weeks treatment period.
Change From Baseline for Worst Pain Intensity as Measured by NRS	-1.45 score on a scale Interval -1.79 to -1.1	-0.97 score on a scale Interval -1.43 to -0.5

SECONDARY outcome

Timeframe: Baseline, Week 8

Population: All enrolled participants who received at least one dose of study drug. Here, the overall number of participants analyzed includes the number of participants with non-missing value at Week 8.

The NRS was used to describe pain severity. Participants were asked to describe their worst pain over the past 24 hours, on a scale of 0 to 10: 0=no pain, and 10=pain as bad as you can imagine.

Posterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.

Outcome measures

Measure	250 mg LY3526318 n=87 Participants Participants received 250 mg of LY3526318 orally, once daily for the first 4 weeks of treatment period and were switched to placebo once daily for the next 4 weeks of the treatment period.	Placebo n=47 Participants Participants received placebo orally, once daily, for 8-weeks treatment period.
Change From Baseline for Worst Pain Intensity as Measured by NRS	-1.69 score on a scale Interval -2.09 to -1.28	-1.18 score on a scale Interval -1.72 to -0.64

SECONDARY outcome

Timeframe: Baseline, Week 4

Population: All enrolled participants who received at least one dose of study drug. Here, the overall number of participants analyzed includes the number of participants with non-missing value at Week 4.

VAS was a graphic, single-item scale where participants were asked to describe their pain intensity over the past week, on a scale of 0 to 100: 0=no pain, and 100=worst imaginable pain. Participants completed the VAS by placing a line perpendicular to the VAS line at a point that described their pain intensity.

Posterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.

Outcome measures

Measure	250 mg LY3526318 n=96 Participants Participants received 250 mg of LY3526318 orally, once daily for the first 4 weeks of treatment period and were switched to placebo once daily for the next 4 weeks of the treatment period.	Placebo n=52 Participants Participants received placebo orally, once daily, for 8-weeks treatment period.
Change From Baseline on the Visual Analog Scale (VAS) for Pain	-14.84 score on a scale Interval -18.65 to -10.99	-9.89 score on a scale Interval -14.97 to -4.8

SECONDARY outcome

Timeframe: Baseline, Week 8

Population: All enrolled participants who received at least one dose of study drug. Here, the overall number of participants analyzed includes the number of participants with non-missing value at Week 8.

VAS was a graphic, single-item scale where participants were asked to describe their pain intensity over the past week, on a scale of 0 to 100: 0=no pain, and 100=worst imaginable pain. Participants completed the VAS by placing a line perpendicular to the VAS line at a point that described their pain intensity.

Posterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.

Outcome measures

Measure	250 mg LY3526318 n=90 Participants Participants received 250 mg of LY3526318 orally, once daily for the first 4 weeks of treatment period and were switched to placebo once daily for the next 4 weeks of the treatment period.	Placebo n=49 Participants Participants received placebo orally, once daily, for 8-weeks treatment period.
Change From Baseline on the Visual Analog Scale (VAS) for Pain	-19.50 score on a scale Interval -23.74 to -15.3	-14.72 score on a scale Interval -20.39 to -9.0

SECONDARY outcome

Timeframe: Baseline, Week 4

Population: All enrolled participants who received at least one dose of study drug. Here, the overall number of participants analyzed includes the number of participants with non-missing value at Week 4.

The MOS Sleep Scale consists of 12 questions addressing the past week. Question 1 asks time to fall asleep and it is reported in 5-point timeframe categories. Question 2 asks average hours of sleep. In the remaining 10 questions participants report how often a sleep symptom or problem was present on a scale ranging from '0=all of the time' to '5=none of the time.' MOS Sleep scale dimension scores range from 0 to 100 with lower score indicating improvement, except for the dimension of sleep adequacy, where higher scores indicate improvement. Here, the average hours of sleep (i.e., Question 2) is reported as the average number of hours slept each night during the past week (range 0 to 24 hours). Higher number of hours slept indicates improvement.

Posterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.

Outcome measures

Measure	250 mg LY3526318 n=96 Participants Participants received 250 mg of LY3526318 orally, once daily for the first 4 weeks of treatment period and were switched to placebo once daily for the next 4 weeks of the treatment period.	Placebo n=52 Participants Participants received placebo orally, once daily, for 8-weeks treatment period.
Change From Baseline on the Sleep Scale From the Medical Outcomes Study (MOS Sleep Scale) - Average Hours of Sleep	0.11 Hours per night Interval -0.09 to 0.32	0.24 Hours per night Interval -0.04 to 0.52

SECONDARY outcome

Timeframe: Baseline, Week 8

Population: All enrolled participants who received at least one dose of study drug. Here, the overall number of participants analyzed includes the number of participants with non-missing value at Week 8.

The MOS Sleep Scale consists of 12 questions addressing the past week. Question 1 asks time to fall asleep and it is reported in 5-point timeframe categories. Question 2 asks average hours of sleep. In the remaining 10 questions participants report how often a sleep symptom or problem was present on a scale ranging from '0=all of the time' to '5=none of the time.' MOS Sleep scale dimension scores range from 0 to 100 with lower score indicating improvement, except for the dimension of sleep adequacy, where higher scores indicate improvement. Here, the average hours of sleep (i.e., Question 2) is reported as the average number of hours slept each night during the past week (range 0 to 24 hours). Higher number of hours slept indicates improvement.

Posterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.

Outcome measures

Measure	250 mg LY3526318 n=90 Participants Participants received 250 mg of LY3526318 orally, once daily for the first 4 weeks of treatment period and were switched to placebo once daily for the next 4 weeks of the treatment period.	Placebo n=49 Participants Participants received placebo orally, once daily, for 8-weeks treatment period.
Change From Baseline on the Sleep Scale From the Medical Outcomes Study (MOS Sleep Scale) - Average Hours of Sleep	5.04 Hours per night Interval 0.08 to 9.95	3.52 Hours per night Interval -2.96 to 10.02

SECONDARY outcome

Timeframe: Baseline, Week 4

Population: All enrolled participants who received at least one dose of study drug. Here, the overall number of participants analyzed includes the number of participants with non-missing value at Week 4.

The EQ-5D-5L assessed quality of life based on 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant was asked to 'check the ONE box that best describes your health TODAY,' choosing from 5 options (no problems, slight problems, moderate problems, severe problems, extreme problems) provided under each dimension. The scores in the 5 dimensions were summarized into a health state index score using the United States algorithm. The health state index value is a single value on a scale from less than 0 to 1 (negative values are valued as worse than dead) with higher scores indicating better health: 0=a health state equivalent to death, and 1=perfect health.

Posterior mean change from baseline, 95% credible intervals was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.

Outcome measures

Measure	250 mg LY3526318 n=96 Participants Participants received 250 mg of LY3526318 orally, once daily for the first 4 weeks of treatment period and were switched to placebo once daily for the next 4 weeks of the treatment period.	Placebo n=52 Participants Participants received placebo orally, once daily, for 8-weeks treatment period.
Change From Baseline on the EuroQuality of Life Five Dimensions (5D) Five Level (5L) Questionnaire (EQ-5D-5L) Health State Index (United States Algorithm)	0.02 score on a scale Interval -0.02 to 0.06	0.01 score on a scale Interval -0.04 to 0.07

SECONDARY outcome

Timeframe: Baseline, Week 8

Population: All enrolled participants who received at least one dose of study drug. Here, the overall number of participants analyzed includes the number of participants with non-missing value at Week 8.

The EQ-5D-5L assessed quality of life based on 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant was asked to 'check the ONE box that best describes your health TODAY,' choosing from 5 options (no problems, slight problems, moderate problems, severe problems, extreme problems) provided under each dimension. The scores in the 5 dimensions were summarized into a health state index score using the United States algorithm. The health state index value is a single value on a scale from less than 0 to 1 (negative values are valued as worse than dead) with higher scores indicating better health: 0=a health state equivalent to death, and 1=perfect health.

Posterior mean change from baseline, 95% credible intervals was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.

Outcome measures

Measure	250 mg LY3526318 n=90 Participants Participants received 250 mg of LY3526318 orally, once daily for the first 4 weeks of treatment period and were switched to placebo once daily for the next 4 weeks of the treatment period.	Placebo n=49 Participants Participants received placebo orally, once daily, for 8-weeks treatment period.
Change From Baseline on the EuroQuality of Life Five Dimensions (5D) Five Level (5L) Questionnaire (EQ-5D-5L) Health State Index (United States Algorithm)	0.05 score on a scale Interval 0.0 to 0.1	0.03 score on a scale Interval -0.04 to 0.1

SECONDARY outcome

Timeframe: Week 4

Population: All enrolled participants who received at least one dose of study drug. Here, the overall number of participants analyzed includes the number of participants with non-missing value at Week 4.

Total amount of rescue medication use as measured by average daily dosage. Posterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.

Outcome measures

Measure	250 mg LY3526318 n=92 Participants Participants received 250 mg of LY3526318 orally, once daily for the first 4 weeks of treatment period and were switched to placebo once daily for the next 4 weeks of the treatment period.	Placebo n=50 Participants Participants received placebo orally, once daily, for 8-weeks treatment period.
Total Amount of Rescue Medication Use as Measured by Average Daily Dosage	229.99 mg per day (mg/day) Interval 148.57 to 311.19	188.27 mg per day (mg/day) Interval 75.5 to 300.88

SECONDARY outcome

Timeframe: Week 8

Population: All enrolled participants who received at least one dose of study drug. Here, the overall number of participants analyzed includes the number of participants with non-missing value at Week 8.

Total amount of rescue medication use as measured by average daily dosage. Posterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.

Outcome measures

Measure	250 mg LY3526318 n=87 Participants Participants received 250 mg of LY3526318 orally, once daily for the first 4 weeks of treatment period and were switched to placebo once daily for the next 4 weeks of the treatment period.	Placebo n=47 Participants Participants received placebo orally, once daily, for 8-weeks treatment period.
Total Amount of Rescue Medication Use as Measured by Average Daily Dosage	237.79 mg per day (mg/day) Interval 144.4 to 332.42	228.06 mg per day (mg/day) Interval 99.15 to 357.46

Adverse Events

250 mg LY3526318 Week 1 to 4

Serious events: 2 serious events

Other events: 36 other events

Deaths: 0 deaths

250 mg LY3526318/Placebo Week 5 to 8

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Placebo Week 1 to 4

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Placebo Week 5 to 8

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	250 mg LY3526318 Week 1 to 4 n=105 participants at risk Participants received 250 mg of LY3526318 orally, once daily for the first 4 weeks of treatment period (Week 1-4).	250 mg LY3526318/Placebo Week 5 to 8 n=92 participants at risk Participants who received 250 mg of LY3526318 in the first 4 weeks were switched to receive placebo once daily for the next 4 weeks of the treatment period (Week 5-8).	Placebo Week 1 to 4 n=54 participants at risk Participants received placebo orally, once daily, for week 1 to 4 of treatment period.	Placebo Week 5 to 8 n=50 participants at risk Participant from Week 1-4 continued to receive placebo orally, once daily, for week 5 to 8 of treatment period.
Injury, poisoning and procedural complications Hip fracture	0.95% 1/105 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/92 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/54 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/50 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.
Psychiatric disorders Suicidal ideation	0.95% 1/105 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/92 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/54 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/50 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.

Other adverse events

Measure	250 mg LY3526318 Week 1 to 4 n=105 participants at risk Participants received 250 mg of LY3526318 orally, once daily for the first 4 weeks of treatment period (Week 1-4).	250 mg LY3526318/Placebo Week 5 to 8 n=92 participants at risk Participants who received 250 mg of LY3526318 in the first 4 weeks were switched to receive placebo once daily for the next 4 weeks of the treatment period (Week 5-8).	Placebo Week 1 to 4 n=54 participants at risk Participants received placebo orally, once daily, for week 1 to 4 of treatment period.	Placebo Week 5 to 8 n=50 participants at risk Participant from Week 1-4 continued to receive placebo orally, once daily, for week 5 to 8 of treatment period.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.95% 1/105 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/92 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/54 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/50 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. 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% 0/105 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/92 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	1.9% 1/54 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/50 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. 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	0.95% 1/105 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/92 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	1.9% 1/54 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	2.0% 1/50 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.
Gastrointestinal disorders Constipation	0.95% 1/105 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/92 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	3.7% 2/54 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/50 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.
Gastrointestinal disorders Nausea	2.9% 3/105 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	1.1% 1/92 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/54 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/50 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.
Nervous system disorders Headache	2.9% 3/105 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	1.1% 1/92 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	3.7% 2/54 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	2.0% 1/50 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. 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 Heavy menstrual bleeding	0.00% 0/66 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/92 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	5.7% 2/35 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/50 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. 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% 0/105 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	1.1% 1/92 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	1.9% 1/54 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/50 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.
Gastrointestinal disorders Diarrhoea	2.9% 3/105 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/92 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/54 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/50 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.
Gastrointestinal disorders Vomiting	1.9% 2/105 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	1.1% 1/92 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/54 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/50 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.
Gastrointestinal disorders Abdominal distentation	0.95% 1/105 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/92 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/54 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/50 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.
Gastrointestinal disorders Abdominal pain	0.95% 1/105 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/92 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/54 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/50 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.
Gastrointestinal disorders Flatulence	0.95% 1/105 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/92 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/54 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/50 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.
Gastrointestinal disorders Frequent bowel movements	0.95% 1/105 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/92 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/54 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/50 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.
Gastrointestinal disorders Lip swelling	0.00% 0/105 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/92 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	1.9% 1/54 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/50 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.
Nervous system disorders Dizziness	2.9% 3/105 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/92 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/54 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/50 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.
Nervous system disorders Somnolence	1.9% 2/105 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/92 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/54 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/50 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.
Nervous system disorders Balance disorder	0.00% 0/105 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/92 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	1.9% 1/54 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/50 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. 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% 0/105 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/92 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	1.9% 1/54 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/50 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.
Nervous system disorders Restless legs syndrome	0.95% 1/105 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/92 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/54 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/50 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.
Nervous system disorders Tension headache	0.95% 1/105 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/92 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/54 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/50 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. 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	1.9% 2/105 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	1.1% 1/92 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	1.9% 1/54 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/50 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. 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	0.95% 1/105 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	1.1% 1/92 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	1.9% 1/54 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/50 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.
Infections and infestations Bronchitis	0.95% 1/105 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/92 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/54 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/50 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. 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% 0/105 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/92 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	1.9% 1/54 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/50 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.
Infections and infestations Nasopharyngitis	0.95% 1/105 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	1.1% 1/92 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/54 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/50 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. 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	0.95% 1/105 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	1.1% 1/92 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/54 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/50 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. 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 Concussion	0.95% 1/105 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/92 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/54 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/50 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. 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% 0/105 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/92 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	1.9% 1/54 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/50 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. 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	0.95% 1/105 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/92 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/54 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/50 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. 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 Hip fracture	0.95% 1/105 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/92 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/54 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/50 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. 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 procedural complication	0.95% 1/105 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/92 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/54 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/50 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. 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 procedural haematoma	0.95% 1/105 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/92 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/54 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/50 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. 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% 0/105 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/92 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	1.9% 1/54 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/50 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. 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% 0/105 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/92 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	1.9% 1/54 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/50 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.
General disorders Fatigue	1.9% 2/105 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/92 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/54 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/50 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.
General disorders Chest discomfort	0.95% 1/105 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/92 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/54 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/50 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.
General disorders Chest pain	0.95% 1/105 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/92 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/54 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/50 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.
General disorders Chills	0.00% 0/105 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/92 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	1.9% 1/54 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/50 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.
General disorders Pain	0.95% 1/105 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/92 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/54 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/50 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. 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 Vaginal discharge*a	1.5% 1/66 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/92 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/35 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/50 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.
Metabolism and nutrition disorders Glucose tolerance impaired	0.95% 1/105 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/92 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/54 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/50 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. 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% 0/105 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/92 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	1.9% 1/54 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/50 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. 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	0.95% 1/105 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/92 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/54 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/50 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.
Cardiac disorders Palpitations	0.00% 0/105 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/92 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	1.9% 1/54 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/50 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.
Cardiac disorders Tachycardia	0.95% 1/105 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/92 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/54 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/50 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. 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	0.95% 1/105 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/92 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/54 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/50 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. 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	0.00% 0/105 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/92 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	1.9% 1/54 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/50 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.
Investigations SARS-CoV-2 test positive	1.9% 2/105 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	1.1% 1/92 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/54 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/50 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.
Psychiatric disorders Insomnia	0.95% 1/105 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	2.2% 2/92 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/54 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/50 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.
Psychiatric disorders Suicidal ideation	0.95% 1/105 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/92 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/54 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/50 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. 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 Nasal congestion	0.00% 0/105 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/92 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	1.9% 1/54 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/50 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. 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 disorder	0.95% 1/105 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/92 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/54 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/50 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. 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	0.95% 1/105 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/92 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/54 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/50 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. 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	0.95% 1/105 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/92 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/54 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/50 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.
Ear and labyrinth disorders Hypoacusis	0.95% 1/105 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/92 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/54 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/50 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.
Eye disorders Photopsia	0.95% 1/105 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/92 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/54 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/50 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. 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) Lipoma	0.95% 1/105 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/92 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/54 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/50 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.
Renal and urinary disorders Urinary retention	0.00% 0/105 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/92 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	1.9% 1/54 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/50 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. 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 allergic	0.00% 0/105 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/92 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	1.9% 1/54 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/50 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.
Vascular disorders Flushing	0.00% 0/105 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/92 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	1.9% 1/54 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/50 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. 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 Haematoma muscle	0.00% 0/105 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/92 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/54 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	2.0% 1/50 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. 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 Muscle spasms	0.00% 0/105 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	1.1% 1/92 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/54 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/50 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. 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% 0/105 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	1.1% 1/92 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/54 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/50 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. 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% 0/105 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/92 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/54 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	2.0% 1/50 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. 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 Facial bones fracture	0.00% 0/105 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	1.1% 1/92 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/54 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/50 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. 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 Fall	0.00% 0/105 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/92 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/54 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	2.0% 1/50 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. 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% 0/105 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	1.1% 1/92 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/54 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/50 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. 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% 0/105 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	1.1% 1/92 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/54 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/50 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.
Nervous system disorders Nerve compression	0.00% 0/105 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/92 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/54 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	2.0% 1/50 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.
Investigations Hepatobiliary scan abnormal	0.00% 0/105 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	1.1% 1/92 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/54 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/50 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. 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% 0/105 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	1.1% 1/92 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/54 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/50 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. 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% 0/105 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	1.1% 1/92 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/54 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.	0.00% 0/50 • Baseline through Week 8 All participants under the safety population for week 1-4 and week 5-8. 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