Trial Outcomes & Findings for Efficacy and Safety of MM-II for Treatment of Knee Pain in Subjects With Symptomatic Knee Osteoarthritis (NCT NCT04506463)

NCT ID: NCT04506463

Last Updated: 2024-08-29

Results Overview

The pain score is based on a score of 0 to 4; the higher the score, the higher the amount of pain.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 397 participants
• Primary outcome timeframe: Week 12
• Results posted on: 2024-08-29

Participant Flow

Participant milestones

Measure	Arm A: MM-II 1 ml MM-II 1 ml MM-II dose I: Intra-articular injection	Arm B: MM-II 3 ml MM-II 3 ml MM-II dose II: Intra-articular injection	Arm C: MM-II 6 ml MM-II 6 ml MM-II dose III: Intra-articular injection	Arm 4: Placebo 1 ml Placebo 1 ml Placebo: Intra-articular injection	Arm 5: Placebo 3 ml Placebo 3 ml Placebo: Intra-articular injection	Arm 6: Placebo 6 ml Placebo 6 ml Placebo: Intra-articular injection
Overall Study STARTED	103	83	76	28	79	28
Overall Study COMPLETED	98	80	66	27	71	27
Overall Study NOT COMPLETED	5	3	10	1	8	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy and Safety of MM-II for Treatment of Knee Pain in Subjects With Symptomatic Knee Osteoarthritis

Baseline characteristics by cohort

Measure	Arm A: MM-II 1 ml n=103 Participants MM-II 1 ml MM-II dose I: Intra-articular injection	Arm B: MM-II 3 ml n=83 Participants MM-II 3 ml MM-II dose II: Intra-articular injection	Arm C: MM-II 6 ml n=76 Participants MM-II 6 ml MM-II dose III: Intra-articular injection	Arm 4: Placebo 1ml n=28 Participants Placebo 1ml Placebo: Intra-articular injection	Arm 5: Placebo 3ml n=79 Participants Placebo 3ml Placebo: Intra-articular injection	Arm 6: Placebo 6ml n=28 Participants Placebo 6ml Placebo: Intra-articular injection	Total n=397 Participants Total of all reporting groups
Age, Customized ≤ 65 Years	65 participants n=5 Participants	41 participants n=7 Participants	52 participants n=5 Participants	19 participants n=4 Participants	50 participants n=21 Participants	15 participants n=10 Participants	242 participants n=115 Participants
Age, Customized > 65 Years	38 participants n=5 Participants	42 participants n=7 Participants	24 participants n=5 Participants	9 participants n=4 Participants	29 participants n=21 Participants	13 participants n=10 Participants	155 participants n=115 Participants
Sex: Female, Male Female	71 Participants n=5 Participants	58 Participants n=7 Participants	39 Participants n=5 Participants	20 Participants n=4 Participants	51 Participants n=21 Participants	19 Participants n=10 Participants	258 Participants n=115 Participants
Sex: Female, Male Male	32 Participants n=5 Participants	25 Participants n=7 Participants	37 Participants n=5 Participants	8 Participants n=4 Participants	28 Participants n=21 Participants	9 Participants n=10 Participants	139 Participants n=115 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	14 Participants n=5 Participants	13 Participants n=7 Participants	16 Participants n=5 Participants	3 Participants n=4 Participants	8 Participants n=21 Participants	5 Participants n=10 Participants	59 Participants n=115 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	89 Participants n=5 Participants	70 Participants n=7 Participants	60 Participants n=5 Participants	25 Participants n=4 Participants	71 Participants n=21 Participants	23 Participants n=10 Participants	338 Participants n=115 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Region of Enrollment Hong Kong	29 participants n=5 Participants	19 participants n=7 Participants	17 participants n=5 Participants	5 participants n=4 Participants	21 participants n=21 Participants	5 participants n=10 Participants	96 participants n=115 Participants
Region of Enrollment United States	27 participants n=5 Participants	37 participants n=7 Participants	32 participants n=5 Participants	10 participants n=4 Participants	27 participants n=21 Participants	14 participants n=10 Participants	147 participants n=115 Participants
Region of Enrollment Denmark	47 participants n=5 Participants	27 participants n=7 Participants	27 participants n=5 Participants	13 participants n=4 Participants	31 participants n=21 Participants	9 participants n=10 Participants	154 participants n=115 Participants

PRIMARY outcome

Timeframe: Week 12

The pain score is based on a score of 0 to 4; the higher the score, the higher the amount of pain.

Outcome measures

Measure	Arm A: MM-II 1 ml n=103 Participants MM-II 1 ml MM-II dose I: Intra-articular injection	Arm B: MM-II 3 ml n=83 Participants MM-II 3 ml MM-II dose II: Intra-articular injection	Arm C: MM-II 6 ml n=76 Participants MM-II 6 ml MM-II dose III: Intra-articular injection	Arm 4: Placebo 1 ml n=28 Participants Placebo 1 ml Placebo: Intra-articular injection	Arm 5: Placebo 3 ml n=78 Participants Placebo 3 ml Placebo: Intra-articular injection	Arm 6: Placebo 6 ml n=28 Participants Placebo 6ml Placebo: Intra-articular injection
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A Pain Score	-1.28 score on a scale Standard Error 0.079	-1.35 score on a scale Standard Error 0.086	-1.14 score on a scale Standard Error 0.092	-0.96 score on a scale Standard Error 0.143	-1.11 score on a scale Standard Error 0.089	-1.10 score on a scale Standard Error 0.142

SECONDARY outcome

Timeframe: Week 26

Knee pain will be assessed on a score of 0 to 100; the lower on the scale, the less the amount of knee pain experienced. Weekly post-baseline average daily knee pain scores will be calculated.

Outcome measures

Measure	Arm A: MM-II 1 ml n=103 Participants MM-II 1 ml MM-II dose I: Intra-articular injection	Arm B: MM-II 3 ml n=83 Participants MM-II 3 ml MM-II dose II: Intra-articular injection	Arm C: MM-II 6 ml n=76 Participants MM-II 6 ml MM-II dose III: Intra-articular injection	Arm 4: Placebo 1 ml n=28 Participants Placebo 1 ml Placebo: Intra-articular injection	Arm 5: Placebo 3 ml n=78 Participants Placebo 3 ml Placebo: Intra-articular injection	Arm 6: Placebo 6 ml n=28 Participants Placebo 6ml Placebo: Intra-articular injection
Change From Baseline in Weekly Average of Daily Knee Pain Scores by VAS	-30.4 score on a scale Standard Error 2.81	-34.5 score on a scale Standard Error 3.08	-23.1 score on a scale Standard Error 3.26	-28.2 score on a scale Standard Error 5.19	-22.7 score on a scale Standard Error 3.20	-30.0 score on a scale Standard Error 5.15

SECONDARY outcome

Timeframe: Week 26

Global pain will be assessed on a score of 0 to 100; the lower on the scale, the less the amount of global pain experienced. Weekly post-baseline average daily global pain scores will be calculated

Outcome measures

Measure	Arm A: MM-II 1 ml n=103 Participants MM-II 1 ml MM-II dose I: Intra-articular injection	Arm B: MM-II 3 ml n=83 Participants MM-II 3 ml MM-II dose II: Intra-articular injection	Arm C: MM-II 6 ml n=76 Participants MM-II 6 ml MM-II dose III: Intra-articular injection	Arm 4: Placebo 1 ml n=28 Participants Placebo 1 ml Placebo: Intra-articular injection	Arm 5: Placebo 3 ml n=78 Participants Placebo 3 ml Placebo: Intra-articular injection	Arm 6: Placebo 6 ml n=28 Participants Placebo 6ml Placebo: Intra-articular injection
Change From Baseline in Weekly Average of Daily Global Pain Scores by VAS	-21.0 score on a scale Standard Error 3.12	-22.1 score on a scale Standard Error 3.54	-14.4 score on a scale Standard Error 3.69	-17.6 score on a scale Standard Error 5.86	-12.2 score on a scale Standard Error 3.55	-26.3 score on a scale Standard Error 6.15

Adverse Events

Arm A: MM-II 1 ml

Serious events: 4 serious events

Other events: 75 other events

Deaths: 0 deaths

Arm B: MM-II 3 ml

Serious events: 0 serious events

Other events: 49 other events

Deaths: 0 deaths

Arm C: MM-II 6 ml

Serious events: 3 serious events

Other events: 49 other events

Deaths: 0 deaths

Arm 4: Placebo 1 ml

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Arm 5: Placebo 3 ml

Serious events: 3 serious events

Other events: 46 other events

Deaths: 0 deaths

Arm 6: Placebo 6 ml

Serious events: 1 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Measure	Arm A: MM-II 1 ml n=102 participants at risk MM-II 1 ml MM-II dose I: Intra-articular injection	Arm B: MM-II 3 ml n=86 participants at risk MM-II 3 ml MM-II dose II: Intra-articular injection	Arm C: MM-II 6 ml n=74 participants at risk MM-II 6 ml MM-II dose III: Intra-articular injection	Arm 4: Placebo 1 ml n=28 participants at risk Placebo 1 ml Placebo: Intra-articular injection	Arm 5: Placebo 3 ml n=78 participants at risk Placebo 3 ml Placebo: Intra-articular injection	Arm 6: Placebo 6 ml n=28 participants at risk Placebo 6 ml Placebo: Intra-articular injection
Endocrine disorders Thyroid cyst	0.98% 1/102 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Cardiac disorders Angina pectoris	0.98% 1/102 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.4% 1/74 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Cardiac disorders Cardiac disorder	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.4% 1/74 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Cardiac disorders Coronary artery disease	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.3% 1/78 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Esophageal adenocarcinoma	0.98% 1/102 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Nervous system disorders Cerebral thrombosis	0.98% 1/102 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.4% 1/74 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	3.6% 1/28 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Blood and lymphatic system disorders Blood loss anemia	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.3% 1/78 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Infections and infestations Pneumonia	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	3.6% 1/28 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	2.6% 2/78 • Number of events 2 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Reproductive system and breast disorders Vaginal hemorrhage	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.3% 1/78 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Vascular disorders Hypertension	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.3% 1/78 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II

Other adverse events

Measure	Arm A: MM-II 1 ml n=102 participants at risk MM-II 1 ml MM-II dose I: Intra-articular injection	Arm B: MM-II 3 ml n=86 participants at risk MM-II 3 ml MM-II dose II: Intra-articular injection	Arm C: MM-II 6 ml n=74 participants at risk MM-II 6 ml MM-II dose III: Intra-articular injection	Arm 4: Placebo 1 ml n=28 participants at risk Placebo 1 ml Placebo: Intra-articular injection	Arm 5: Placebo 3 ml n=78 participants at risk Placebo 3 ml Placebo: Intra-articular injection	Arm 6: Placebo 6 ml n=28 participants at risk Placebo 6 ml Placebo: Intra-articular injection
General disorders Influenza like illness	4.9% 5/102 • Number of events 6 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.2% 1/86 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	2.7% 2/74 • Number of events 2 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	10.7% 3/28 • Number of events 3 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	3.8% 3/78 • Number of events 4 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	3.6% 1/28 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Musculoskeletal and connective tissue disorders Arthralgia	6.9% 7/102 • Number of events 7 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	5.8% 5/86 • Number of events 5 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	13.5% 10/74 • Number of events 12 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	3.6% 1/28 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	7.7% 6/78 • Number of events 8 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	10.7% 3/28 • Number of events 3 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Musculoskeletal and connective tissue disorders Joint instability	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.2% 1/86 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Musculoskeletal and connective tissue disorders Joint stiffness	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.4% 1/74 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Musculoskeletal and connective tissue disorders Joint swelling	0.98% 1/102 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.4% 1/74 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.3% 1/78 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	7.1% 2/28 • Number of events 2 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Musculoskeletal and connective tissue disorders Pain in extremity	2.9% 3/102 • Number of events 3 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.2% 1/86 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	2.7% 2/74 • Number of events 2 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	5.1% 4/78 • Number of events 4 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	3.6% 1/28 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
General disorders Injection site joint pain	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	2.3% 2/86 • Number of events 2 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	2.7% 2/74 • Number of events 2 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
General disorders Gait disturbance	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.2% 1/86 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	3.6% 1/28 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
General disorders Injection site pruritus	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.3% 1/78 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Skin and subcutaneous tissue disorders Urticaria	0.98% 1/102 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Gastrointestinal disorders Abdominal pain upper	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.2% 1/86 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	3.6% 1/28 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Infections and infestations COVID-19	17.6% 18/102 • Number of events 18 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	8.1% 7/86 • Number of events 7 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	9.5% 7/74 • Number of events 7 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	14.3% 4/28 • Number of events 4 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	10.3% 8/78 • Number of events 8 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	10.7% 3/28 • Number of events 3 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Infections and infestations Nasopharyngitis	7.8% 8/102 • Number of events 8 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	3.5% 3/86 • Number of events 3 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	8.1% 6/74 • Number of events 6 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	3.6% 1/28 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	3.8% 3/78 • Number of events 3 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	7.1% 2/28 • Number of events 2 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Infections and infestations Urinary tract infection	4.9% 5/102 • Number of events 5 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	2.7% 2/74 • Number of events 2 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	5.1% 4/78 • Number of events 4 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	7.1% 2/28 • Number of events 2 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Infections and infestations Cystitis	2.0% 2/102 • Number of events 2 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.2% 1/86 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.3% 1/78 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Infections and infestations Gastroenteritis viral	2.0% 2/102 • Number of events 2 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.4% 1/74 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	3.6% 1/28 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.3% 1/78 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Infections and infestations Pneumonia	0.98% 1/102 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	2.3% 2/86 • Number of events 3 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.3% 1/78 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	7.1% 2/28 • Number of events 2 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Infections and infestations Upper respiratory tract infection	0.98% 1/102 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.2% 1/86 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.4% 1/74 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.3% 1/78 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Infections and infestations Bronchitis	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	2.3% 2/86 • Number of events 2 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Infections and infestations Gastroenteritis	2.0% 2/102 • Number of events 2 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.3% 1/78 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Infections and infestations Influenza	2.0% 2/102 • Number of events 2 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Infections and infestations Otitis externa	0.98% 1/102 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.4% 1/74 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Infections and infestations Root canal infection	0.98% 1/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.2% 1/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Infections and infestations Sinusitis	0.98% 1/102 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.2% 1/86 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.3% 1/78 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Infections and infestations Tooth infection	0.98% 1/102 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.2% 1/86 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	3.6% 1/28 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Infections and infestations Bacterial infection	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.2% 1/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Infections and infestations Conjunctivitis	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.4% 1/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Infections and infestations Herpes zoster	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.2% 1/86 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Infections and infestations Infected bite	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.4% 1/74 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Infections and infestations Oral herpes	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.2% 1/86 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Infections and infestations Oral infection	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.4% 1/74 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Infections and infestations Post procedural infection	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.2% 1/86 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Infections and infestations Viral upper respiratory tract infection	0.98% 1/102 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Infections and infestations Acarodermatitis	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.3% 1/78 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Infections and infestations Ear infection	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	3.6% 1/28 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Infections and infestations Hordeolum	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.3% 1/78 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Infections and infestations Pharyngitis	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	3.6% 1/28 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Infections and infestations Respiratory tract infection	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.3% 1/78 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Infections and infestations Skin infection	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.3% 1/78 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Musculoskeletal and connective tissue disorders Back pain	2.9% 3/102 • Number of events 3 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	5.8% 5/86 • Number of events 5 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	4.1% 3/74 • Number of events 3 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	2.6% 2/78 • Number of events 2 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Musculoskeletal and connective tissue disorders Myalgia	2.0% 2/102 • Number of events 2 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	4.1% 3/74 • Number of events 3 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Musculoskeletal and connective tissue disorders Osteoarthritis	0.98% 1/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.4% 1/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	3.6% 1/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	2.6% 2/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Musculoskeletal and connective tissue disorders Osteoporosis	0.98% 1/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.2% 1/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Musculoskeletal and connective tissue disorders Synovial cyst	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	2.3% 2/86 • Number of events 2 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Musculoskeletal and connective tissue disorders Costochondritis	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.4% 1/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Musculoskeletal and connective tissue disorders Exostosis	0.98% 1/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Musculoskeletal and connective tissue disorders Joint effusion	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.4% 1/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Musculoskeletal and connective tissue disorders Mandibular mass	0.98% 1/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Musculoskeletal and connective tissue disorders Metatarsalgia	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.2% 1/86 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.98% 1/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	3.6% 1/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.3% 1/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.98% 1/102 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.3% 1/78 • Number of events 2 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.4% 1/74 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	2.6% 2/78 • Number of events 2 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Musculoskeletal and connective tissue disorders Osteopenia	0.98% 1/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Musculoskeletal and connective tissue disorders Patellofemoral pain syndrome	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.4% 1/74 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.98% 1/102 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Musculoskeletal and connective tissue disorders Trigger finger	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.2% 1/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Musculoskeletal and connective tissue disorders Soft tissue swelling	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	3.6% 1/28 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	3.6% 1/28 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Blood and lymphatic system disorders Leukopenia	3.9% 4/102 • Number of events 4 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	7.0% 6/86 • Number of events 6 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	4.1% 3/74 • Number of events 3 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	3.6% 1/28 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	2.6% 2/78 • Number of events 2 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	10.7% 3/28 • Number of events 3 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Blood and lymphatic system disorders Anaemia	6.9% 7/102 • Number of events 7 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	3.5% 3/86 • Number of events 3 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	2.7% 2/74 • Number of events 2 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	5.1% 4/78 • Number of events 4 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Blood and lymphatic system disorders Thrombocytopenia	0.98% 1/102 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.2% 1/86 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	3.6% 1/28 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	3.6% 1/28 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Blood and lymphatic system disorders Blood loss anaemia	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.3% 1/78 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Injury, poisoning and procedural complications Ligament sprain	2.9% 3/102 • Number of events 3 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	2.7% 2/74 • Number of events 2 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	3.8% 3/78 • Number of events 3 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Injury, poisoning and procedural complications Vaccination complication	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	5.4% 4/74 • Number of events 4 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	10.7% 3/28 • Number of events 3 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.3% 1/78 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	3.6% 1/28 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Injury, poisoning and procedural complications Joint injury	2.9% 3/102 • Number of events 4 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.3% 1/78 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Injury, poisoning and procedural complications Foot fracture	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.2% 1/86 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.4% 1/74 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	3.6% 1/28 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Injury, poisoning and procedural complications Procedural pain	0.98% 1/102 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.2% 1/86 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.3% 1/78 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Injury, poisoning and procedural complications Cataract operation complication	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.2% 1/86 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Injury, poisoning and procedural complications Epicondylitis	0.98% 1/102 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Injury, poisoning and procedural complications Fall	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.4% 1/74 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	7.1% 2/28 • Number of events 2 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Injury, poisoning and procedural complications Limb injury	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.4% 1/74 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Injury, poisoning and procedural complications Muscle injury	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.4% 1/74 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.4% 1/74 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Injury, poisoning and procedural complications Wound	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.4% 1/74 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	3.6% 1/28 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Injury, poisoning and procedural complications Buttock injury	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.3% 1/78 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Injury, poisoning and procedural complications Chest injury	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.3% 1/78 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	3.6% 1/28 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Injury, poisoning and procedural complications Contusion	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	7.1% 2/28 • Number of events 2 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.3% 1/78 • Number of events 2 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Injury, poisoning and procedural complications Muscle strain	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	3.6% 1/28 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Injury, poisoning and procedural complications Radius fracture	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	3.6% 1/28 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	2.6% 2/78 • Number of events 2 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Injury, poisoning and procedural complications Skin laceration	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	3.6% 1/28 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
General disorders Chest pain	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.2% 1/86 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.4% 1/74 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
General disorders Chills	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.4% 1/74 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
General disorders Non-cardiac chest pain	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.4% 1/74 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
General disorders Pyrexia	0.98% 1/102 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
General disorders Pain	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	3.6% 1/28 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Investigations White blood cells urine	2.9% 3/102 • Number of events 3 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.3% 1/78 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Investigations Hepatic enzyme increased	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.2% 1/86 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.4% 1/74 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Investigations White blood cells urine positive	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	2.3% 2/86 • Number of events 2 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Investigations Blood cholesterol increased	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.4% 1/74 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Investigations Blood creatine phosphokinase increased	0.98% 1/102 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Investigations Blood glucose decreased	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.4% 1/74 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Investigations Blood pressure increased	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.4% 1/74 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Investigations Electrocardiogram QT interval normal	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.2% 1/86 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Investigations Electrocardiogram T wave inversion	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.4% 1/74 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Investigations Haemoglobin decreased	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.4% 1/74 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	3.6% 1/28 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Investigations Platelet count increased	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.4% 1/74 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Investigations White blood cell count increased	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.4% 1/74 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Investigations Alanine aminotransferase increased	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.3% 1/78 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Investigations Blood creatinine increased	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	3.6% 1/28 • Number of events 2 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Investigations Blood glucose increased	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	3.6% 1/28 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Investigations Blood potassium increased	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.3% 1/78 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Investigations Gamma-glutamyltran sferase increased	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.3% 1/78 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Gastrointestinal disorders Diarrhoea	0.98% 1/102 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	8.1% 7/86 • Number of events 11 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	5.4% 4/74 • Number of events 4 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	7.1% 2/28 • Number of events 2 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	10.3% 8/78 • Number of events 8 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Gastrointestinal disorders Toothache	0.98% 1/102 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	2.3% 2/86 • Number of events 2 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	2.7% 2/74 • Number of events 2 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.3% 1/78 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Gastrointestinal disorders Abdominal pain	2.0% 2/102 • Number of events 2 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Gastrointestinal disorders Anal haemorrhage	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.2% 1/86 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Gastrointestinal disorders Constipation	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.2% 1/86 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Gastrointestinal disorders Dental caries	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.2% 1/86 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Gastrointestinal disorders Dysphagia	0.98% 1/102 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Gastrointestinal disorders Nausea	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.2% 1/86 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.3% 1/78 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Gastrointestinal disorders Paraesthesia oral	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.2% 1/86 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Gastrointestinal disorders Proctitis	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.2% 1/86 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Gastrointestinal disorders Dyspepsia	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	10.7% 3/28 • Number of events 3 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Gastrointestinal disorders Gastritis	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.3% 1/78 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Gastrointestinal disorders Haemorrhoids	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.3% 1/78 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Gastrointestinal disorders Salivary gland pain	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.3% 1/78 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Metabolism and nutrition disorders Hypercholesterolaemia	2.9% 3/102 • Number of events 3 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.4% 1/74 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.3% 1/78 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	3.6% 1/28 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Metabolism and nutrition disorders Hyperlipidaemia	2.0% 2/102 • Number of events 2 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	2.7% 2/74 • Number of events 2 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	5.1% 4/78 • Number of events 4 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Metabolism and nutrition disorders Type 2 diabetes mellitus	2.9% 3/102 • Number of events 3 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.4% 1/74 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	3.6% 1/28 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Metabolism and nutrition disorders Glucose tolerance impaired	0.98% 1/102 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	2.3% 2/86 • Number of events 2 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	3.6% 1/28 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	2.6% 2/78 • Number of events 2 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Metabolism and nutrition disorders Impaired fasting glucose	0.98% 1/102 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.4% 1/74 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Metabolism and nutrition disorders Diabetes mellitus	0.98% 1/102 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Metabolism and nutrition disorders Gout	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.3% 1/78 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Vascular disorders Hypertension	7.8% 8/102 • Number of events 8 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	3.5% 3/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	4.1% 3/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	3.8% 3/78 • Number of events 4 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Vascular disorders Thrombophlebitis superficial	0.98% 1/102 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Cardiac disorders Angina pectoris	0.98% 1/102 • Number of events 2 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.4% 1/74 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Cardiac disorders Bradycardia	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.4% 1/74 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Cardiac disorders Bundle branch block left	0.98% 1/102 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Cardiac disorders Cardiac disorder	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.4% 1/74 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Cardiac disorders Myocardial ischaemia	0.98% 1/102 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Cardiac disorders Sinus bradycardia	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.2% 1/86 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Cardiac disorders Ventricular extrasystoles	0.98% 1/102 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Cardiac disorders Coronary artery disease	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.3% 1/78 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Cardiac disorders Palpitations	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.3% 1/78 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Nervous system disorders Hypoaesthesia	0.98% 1/102 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.4% 1/74 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Nervous system disorders Cerebral thrombosis	0.98% 1/102 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Nervous system disorders Cubital tunnel syndrome	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.4% 1/74 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Nervous system disorders Headache	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.4% 1/74 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	2.6% 2/78 • Number of events 2 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	3.6% 1/28 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Nervous system disorders Post-traumatic headache	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.2% 1/86 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Nervous system disorders Tremor	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.2% 1/86 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.4% 1/74 • Number of events 2 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.2% 1/86 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.3% 1/78 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.2% 1/86 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Respiratory, thoracic and mediastinal disorders Nasal oedema	0.98% 1/102 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Respiratory, thoracic and mediastinal disorders Nasal polyps	0.98% 1/102 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.4% 1/74 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.2% 1/86 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	2.6% 2/78 • Number of events 2 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	3.6% 1/28 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Skin and subcutaneous tissue disorders Rash	2.0% 2/102 • Number of events 2 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.4% 1/74 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Skin and subcutaneous tissue disorders Dermatitis atopic	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.2% 1/86 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	3.6% 1/28 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Skin and subcutaneous tissue disorders Eczema	0.98% 1/102 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	3.6% 1/28 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Eye disorders Cataract	0.98% 1/102 • Number of events 2 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.2% 1/86 • Number of events 2 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Eye disorders Age-related macular degeneration	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.2% 1/86 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Eye disorders Keratitis	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.4% 1/74 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign neoplasm of skin	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.2% 1/86 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemangioma of liver	0.98% 1/102 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal adenocarcinoma	0.98% 1/102 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.4% 1/74 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Melanocytic naevus	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	3.6% 1/28 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Congenital, familial and genetic disorders Thalassaemia minor	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.2% 1/86 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.4% 1/74 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Endocrine disorders Hypothyroidism	0.98% 1/102 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	3.6% 1/28 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Endocrine disorders Thyroid cyst	0.98% 1/102 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Hepatobiliary disorders Gallbladder polyp	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.2% 1/86 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Hepatobiliary disorders Hepatic cyst	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.2% 1/86 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Psychiatric disorders Insomnia	0.98% 1/102 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Psychiatric disorders Anxiety	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.3% 1/78 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.4% 1/74 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	3.6% 1/28 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Reproductive system and breast disorders Atrophic vulvovaginitis	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	3.6% 1/28 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	1.3% 1/78 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II
Renal and urinary disorders Haematuria	0.00% 0/102 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/86 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/74 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	3.6% 1/28 • Number of events 1 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/78 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II	0.00% 0/28 • 27 week Safety was assessed using the Safety Analysis Set.The Safety Analysis Set will include all randomized subjects who received the single dose of IP. Note:Two subjects were randomized to 6 mL MM-II but received 3 mL MM-II; One subject was randomized to 1 mL MM-II but received 3 mL MM-II

Additional Information

Head-Clinical Development

Sun Pharmaceutical Industries Limited

Phone: 2266455645

Email: Clinical.Trial@sunpharma.com

Results disclosure agreements

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