Trial Outcomes & Findings for A Study of ALKS 3831 in Adults With Schizophrenia (NCT NCT01903837)

NCT ID: NCT01903837

Last Updated: 2021-10-06

Results Overview

Change from baseline (Day 8) to Day 92 (end of study Part A). The PANSS is a 30-item scale measuring severity of schizophrenia symptoms. Symptom severity for each item is rated on a 7-point scale (1 = absent; 7 = extreme), and the total score is added together, with a minimum score of 30 and a maximum score of 210. A higher score indicates more severe symptoms, while a lower score indicates less severe symptoms.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 347 participants
• Primary outcome timeframe: Baseline (Day 8) to Day 92 (end of study Part A)
• Results posted on: 2021-10-06

Participant Flow

This study included subjects who had a diagnosis of schizophrenia and who had not been exposed to olanzapine, clozapine, mesoridazine, chlorpromazine, or thioridazine for more than 1 week within the previous year or at any time in the 3 months prior to screening. Subjects were enrolled in study sites located in 3 countries: United States, Bulgaria, and the Czech Republic.

Subjects completed a seven-day lead-in period on open-label olanzapine before being randomized into the 12-week double-blind treatment period. Baseline data includes subjects who completed the lead-in period and were randomized to a treatment group. A total of 347 subjects were enrolled in the study; 309 subjects completed the 1-week olanzapine lead-in period and were randomized to one of the 4 treatment groups in Part A

Participant milestones

Measure	Olz + Placebo/ Olz+Sam 20mg Part A: Olanzapine (dose level determined by Investigator) + placebo tablets taken once daily Part B: Olanzapine (dose level determined by Investigator) + 20mg Samidorphan tablets taken once daily Subjects were transitioned from placebo in Part A to 20mg Samidorphan in Part B	Olz + Sam 5mg / Olz + Sam 5mg Part A: Olanzapine (dose level determined by Investigator) + 5mg samidorphan tablets taken once daily Part B: Olanzapine (dose level determined by Investigator) + 5mg samidorphan tablets taken once daily	Olz + Sam 10mg /Olz + Sam 10mg Part A: Olanzapine (dose level determined by Investigator) + 10mg Samidorphan tablets taken once daily Part B: Olanzapine (dose level determined by Investigator) + 10mg Samidorphan tablets taken once daily	Olz + Sam 20mg/ Olz + Sam 20mg Part A: Olanzapine (dose level determined by Investigator) + 20mg samidorphan tablets taken once daily Part B: Olanzapine (dose level determined by Investigator) + 20mg samidorphan tablets taken once daily
Part A STARTED	75	80	86	68
Part A COMPLETED	56	52	58	55
Part A NOT COMPLETED	19	28	28	13
Part B STARTED	54	52	57	55
Part B COMPLETED	45	46	52	44
Part B NOT COMPLETED	9	6	5	11

Reasons for withdrawal

Measure	Olz + Placebo/ Olz+Sam 20mg Part A: Olanzapine (dose level determined by Investigator) + placebo tablets taken once daily Part B: Olanzapine (dose level determined by Investigator) + 20mg Samidorphan tablets taken once daily Subjects were transitioned from placebo in Part A to 20mg Samidorphan in Part B	Olz + Sam 5mg / Olz + Sam 5mg Part A: Olanzapine (dose level determined by Investigator) + 5mg samidorphan tablets taken once daily Part B: Olanzapine (dose level determined by Investigator) + 5mg samidorphan tablets taken once daily	Olz + Sam 10mg /Olz + Sam 10mg Part A: Olanzapine (dose level determined by Investigator) + 10mg Samidorphan tablets taken once daily Part B: Olanzapine (dose level determined by Investigator) + 10mg Samidorphan tablets taken once daily	Olz + Sam 20mg/ Olz + Sam 20mg Part A: Olanzapine (dose level determined by Investigator) + 20mg samidorphan tablets taken once daily Part B: Olanzapine (dose level determined by Investigator) + 20mg samidorphan tablets taken once daily
Part A Withdrawal by Subject	4	9	8	5
Part A Adverse Event	3	6	9	6
Part A Lost to Follow-up	9	7	7	2
Part A Non-compliance with study drug	1	4	4	0
Part A Physician Decision	1	1	0	0
Part A Protocol Violation	1	1	0	0
Part B Lost to Follow-up	0	3	3	4
Part B Withdrawal by Subject	1	2	0	3
Part B Adverse Event	3	0	2	0
Part B Non-compliance with study drug	2	0	0	1
Part B Incarceration	2	0	0	1
Part B Physician Decision	1	0	0	2
Part B Lack of Efficacy	0	1	0	0

Baseline Characteristics

A Study of ALKS 3831 in Adults With Schizophrenia

Baseline characteristics by cohort

Measure	Olz + Placebo n=75 Participants Olanzapine (dose level determined by Investigator) and placebo tablets taken once daily	Olz + Sam 5mg n=80 Participants Olanzapine (dose level determined by Investigator) and 5mg Samidorphan tablets taken once daily	Olz + Sam 10mg n=86 Participants Olanzapine (dose level determined by Investigator) and 10mg Samidorphan tablets taken once daily	Olz + Sam 20mg n=68 Participants Olanzapine (dose level determined by Investigator) and 20mg Samidorphan tablets taken once daily	Total n=309 Participants Total of all reporting groups
Age, Continuous	40.3 years STANDARD_DEVIATION 8.14 • n=93 Participants	37.9 years STANDARD_DEVIATION 8.62 • n=4 Participants	38.1 years STANDARD_DEVIATION 8.00 • n=27 Participants	39.3 years STANDARD_DEVIATION 8.38 • n=483 Participants	38.8 years STANDARD_DEVIATION 8.30 • n=36 Participants
Sex: Female, Male Female	22 Participants n=93 Participants	20 Participants n=4 Participants	21 Participants n=27 Participants	18 Participants n=483 Participants	81 Participants n=36 Participants
Sex: Female, Male Male	53 Participants n=93 Participants	60 Participants n=4 Participants	65 Participants n=27 Participants	50 Participants n=483 Participants	228 Participants n=36 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=93 Participants	5 Participants n=4 Participants	5 Participants n=27 Participants	3 Participants n=483 Participants	17 Participants n=36 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	71 Participants n=93 Participants	75 Participants n=4 Participants	81 Participants n=27 Participants	65 Participants n=483 Participants	292 Participants n=36 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Asian	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants	2 Participants n=483 Participants	4 Participants n=36 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants	3 Participants n=36 Participants
Race (NIH/OMB) Black or African American	44 Participants n=93 Participants	53 Participants n=4 Participants	50 Participants n=27 Participants	42 Participants n=483 Participants	189 Participants n=36 Participants
Race (NIH/OMB) White	28 Participants n=93 Participants	26 Participants n=4 Participants	35 Participants n=27 Participants	23 Participants n=483 Participants	112 Participants n=36 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	1 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	1 Participants n=36 Participants
Region of Enrollment United States	60 Participants n=93 Participants	68 Participants n=4 Participants	70 Participants n=27 Participants	60 Participants n=483 Participants	258 Participants n=36 Participants
Region of Enrollment Czechia	0 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants	0 Participants n=483 Participants	1 Participants n=36 Participants
Region of Enrollment Bulgaria	15 Participants n=93 Participants	12 Participants n=4 Participants	15 Participants n=27 Participants	8 Participants n=483 Participants	50 Participants n=36 Participants
Height	173.4 centimeters STANDARD_DEVIATION 8.07 • n=93 Participants	173.5 centimeters STANDARD_DEVIATION 10.76 • n=4 Participants	174.8 centimeters STANDARD_DEVIATION 10.27 • n=27 Participants	174.1 centimeters STANDARD_DEVIATION 9.99 • n=483 Participants	174 centimeters STANDARD_DEVIATION 9.82 • n=36 Participants
Weight	75.6 kilograms STANDARD_DEVIATION 12.30 • n=93 Participants	77.5 kilograms STANDARD_DEVIATION 13.07 • n=4 Participants	76.7 kilograms STANDARD_DEVIATION 13.67 • n=27 Participants	75.4 kilograms STANDARD_DEVIATION 12.81 • n=483 Participants	76.4 kilograms STANDARD_DEVIATION 12.96 • n=36 Participants
Body Mass Index (BMI)	25.1 kilograms/meters^2 STANDARD_DEVIATION 3.40 • n=93 Participants	25.7 kilograms/meters^2 STANDARD_DEVIATION 3.18 • n=4 Participants	25.0 kilograms/meters^2 STANDARD_DEVIATION 3.23 • n=27 Participants	24.8 kilograms/meters^2 STANDARD_DEVIATION 3.41 • n=483 Participants	25.2 kilograms/meters^2 STANDARD_DEVIATION 3.30 • n=36 Participants
Body Mass Index (BMI) Group Underweight (<18.5)	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants	1 Participants n=483 Participants	3 Participants n=36 Participants
Body Mass Index (BMI) Group Normal (18.5 to <25)	32 Participants n=93 Participants	31 Participants n=4 Participants	42 Participants n=27 Participants	32 Participants n=483 Participants	137 Participants n=36 Participants
Body Mass Index (BMI) Group Overweight (25 to <30)	42 Participants n=93 Participants	46 Participants n=4 Participants	43 Participants n=27 Participants	34 Participants n=483 Participants	165 Participants n=36 Participants
Body Mass Index (BMI) Group Obese (>=30)	0 Participants n=93 Participants	3 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants	4 Participants n=36 Participants

PRIMARY outcome

Timeframe: Baseline (Day 8) to Day 92 (end of study Part A)

Population: Full Analysis Set (FAS) 1 efficacy analysis population included all randomized subjects who received at least one dose of study drug and had at least one postbaseline assessment of Positive and Negative Syndrome Scale (PANSS) total score.

Change from baseline (Day 8) to Day 92 (end of study Part A).

The PANSS is a 30-item scale measuring severity of schizophrenia symptoms. Symptom severity for each item is rated on a 7-point scale (1 = absent; 7 = extreme), and the total score is added together, with a minimum score of 30 and a maximum score of 210. A higher score indicates more severe symptoms, while a lower score indicates less severe symptoms.

Outcome measures

Measure	Part A FAS 1- Olz + Sam 5mg n=75 Participants Subjects who were randomized to olanzapine + samidorphan 5mg in study Part A, received at least one dose of study drug, and had at least one post-baseline assessment of PANSS total score	Part A FAS 1- Olz + Sam 10mg n=83 Participants Subjects who were randomized to olanzapine + samidorphan 10mg in study Part A, received at least one dose of study drug, and had at least one post-baseline assessment of PANSS total score	Part A FAS 1- Olz + Sam 20mg n=68 Participants Subjects who were randomized to olanzapine + samidorphan 20mg in study Part A, received at least one dose of study drug, and had at least one post-baseline assessment of PANSS total score	Part A FAS 2- Olz + Placebo All FAS 1 subjects who were randomized to olanzapine + placebo in study Part A, gained weight during the first week of olanzapine treatment prior to randomization and had at least one post-baseline weight assessment.	Part A FAS 2- Olz + Sam 5mg All FAS 1 subjects who were randomized to olanzapine + samidorphan 5mg in study Part A, gained weight during the first week of olanzapine treatment prior to randomization and had at least one post-baseline weight assessment.	Part A FAS 2- Olz + Sam 10mg Subjects who were randomized to olanzapine + samidorphan 10mg in study Part A, received at least one dose of study drug, and had at least one post-baseline assessment of PANSS total score	Part A FAS 2- Olz + Sam 20mg Subjects who were randomized to olanzapine + samidorphan 20mg in study Part A, received at least one dose of study drug, and had at least one post-baseline assessment of PANSS total score	Part A FAS 1 - OLZ + Placebo n=74 Participants Subjects who were randomized to olanzapine + placebo in study Part A, received at least one dose of study drug, and had at least one post-baseline assessment of PANSS total score
Absolute Change in Total Positive and Negative Syndrome Scale (PANSS) Score	-1.5 units on a scale Standard Error 0.85	-2.7 units on a scale Standard Error 0.79	-2.5 units on a scale Standard Error 0.83	—	—	—	—	-2.9 units on a scale Standard Error 0.82

SECONDARY outcome

Timeframe: Baseline (Day 8) to Day 92 (end of study Part A)

Population: Full Analysis Set (FAS) 1 efficacy analysis population included all randomized subjects who received at least one dose of study drug and had at least one postbaseline assessment of Positive and Negative Syndrome Scale (PANSS) total score. FAS 2 efficacy analysis population included all FAS 1 subjects who gained weight during the 1-week OLZ lead-in period prior to randomization and had at least one postbaseline weight assessment.

Percent change from baseline (Day 8) to the end of Part A (Day 92)

Outcome measures

Measure	Part A FAS 1- Olz + Sam 5mg n=75 Participants Subjects who were randomized to olanzapine + samidorphan 5mg in study Part A, received at least one dose of study drug, and had at least one post-baseline assessment of PANSS total score	Part A FAS 1- Olz + Sam 10mg n=83 Participants Subjects who were randomized to olanzapine + samidorphan 10mg in study Part A, received at least one dose of study drug, and had at least one post-baseline assessment of PANSS total score	Part A FAS 1- Olz + Sam 20mg n=67 Participants Subjects who were randomized to olanzapine + samidorphan 20mg in study Part A, received at least one dose of study drug, and had at least one post-baseline assessment of PANSS total score	Part A FAS 2- Olz + Placebo n=45 Participants All FAS 1 subjects who were randomized to olanzapine + placebo in study Part A, gained weight during the first week of olanzapine treatment prior to randomization and had at least one post-baseline weight assessment.	Part A FAS 2- Olz + Sam 5mg n=50 Participants All FAS 1 subjects who were randomized to olanzapine + samidorphan 5mg in study Part A, gained weight during the first week of olanzapine treatment prior to randomization and had at least one post-baseline weight assessment.	Part A FAS 2- Olz + Sam 10mg n=53 Participants Subjects who were randomized to olanzapine + samidorphan 10mg in study Part A, received at least one dose of study drug, and had at least one post-baseline assessment of PANSS total score	Part A FAS 2- Olz + Sam 20mg n=46 Participants Subjects who were randomized to olanzapine + samidorphan 20mg in study Part A, received at least one dose of study drug, and had at least one post-baseline assessment of PANSS total score	Part A FAS 1 - OLZ + Placebo n=74 Participants Subjects who were randomized to olanzapine + placebo in study Part A, received at least one dose of study drug, and had at least one post-baseline assessment of PANSS total score
Percent Change in Body Weight (Kilogram) From Baseline to Day 92	2.8 percent change Interval 1.8 to 3.7	2.1 percent change Interval 1.3 to 3.0	2.9 percent change Interval 1.9 to 3.8	5.3 percent change Interval 4.2 to 6.4	3.8 percent change Interval 2.7 to 4.9	2.2 percent change Interval 1.2 to 3.3	1.6 percent change Interval 0.5 to 2.7	4.1 percent change Interval 3.2 to 5.0

SECONDARY outcome

Timeframe: Baseline (Day 8) to Day 92 (end of study Part A)

Population: Full Analysis Set (FAS) 1 efficacy analysis population included all randomized subjects who received at least one dose of study drug and had at least one postbaseline assessment of Positive and Negative Syndrome Scale (PANSS) total score. FAS 2 efficacy analysis population included all FAS 1 subjects who gained weight during the 1-week OLZ lead-in period prior to randomization and had at least one postbaseline weight assessment.

Change from randomization (Day 8) to the end of Part A (Week 12; Day 92)

Outcome measures

Measure	Part A FAS 1- Olz + Sam 5mg n=75 Participants Subjects who were randomized to olanzapine + samidorphan 5mg in study Part A, received at least one dose of study drug, and had at least one post-baseline assessment of PANSS total score	Part A FAS 1- Olz + Sam 10mg n=83 Participants Subjects who were randomized to olanzapine + samidorphan 10mg in study Part A, received at least one dose of study drug, and had at least one post-baseline assessment of PANSS total score	Part A FAS 1- Olz + Sam 20mg n=67 Participants Subjects who were randomized to olanzapine + samidorphan 20mg in study Part A, received at least one dose of study drug, and had at least one post-baseline assessment of PANSS total score	Part A FAS 2- Olz + Placebo n=45 Participants All FAS 1 subjects who were randomized to olanzapine + placebo in study Part A, gained weight during the first week of olanzapine treatment prior to randomization and had at least one post-baseline weight assessment.	Part A FAS 2- Olz + Sam 5mg n=50 Participants All FAS 1 subjects who were randomized to olanzapine + samidorphan 5mg in study Part A, gained weight during the first week of olanzapine treatment prior to randomization and had at least one post-baseline weight assessment.	Part A FAS 2- Olz + Sam 10mg n=53 Participants Subjects who were randomized to olanzapine + samidorphan 10mg in study Part A, received at least one dose of study drug, and had at least one post-baseline assessment of PANSS total score	Part A FAS 2- Olz + Sam 20mg n=47 Participants Subjects who were randomized to olanzapine + samidorphan 20mg in study Part A, received at least one dose of study drug, and had at least one post-baseline assessment of PANSS total score	Part A FAS 1 - OLZ + Placebo n=74 Participants Subjects who were randomized to olanzapine + placebo in study Part A, received at least one dose of study drug, and had at least one post-baseline assessment of PANSS total score
Absolute Change in Body Weight (kg) From Baseline to Day 92	2.1 kg Interval 1.4 to 2.8	1.5 kg Interval 0.9 to 2.2	2.2 kg Interval 1.5 to 2.9	3.8 kg Interval 2.9 to 4.6	2.9 kg Interval 2.1 to 3.7	1.5 kg Interval 0.7 to 2.3	1.2 kg Interval 0.4 to 2.1	2.9 kg Interval 2.2 to 3.6

SECONDARY outcome

Timeframe: Baseline (Day 8) to Day 92 (end of study Part A)

Population: Full Analysis Set (FAS) 1 efficacy analysis population included all randomized subjects who received at least one dose of study drug and had at least one postbaseline assessment of Positive and Negative Syndrome Scale (PANSS) total score. FAS 2 efficacy analysis population included all FAS 1 subjects who gained weight during the 1-week OLZ lead-in period prior to randomization and had at least one postbaseline weight assessment.

Significant weight gain will include a >=5%, >= 7%, or >=10% gain in body weight from baseline (Day 8) to Day 92 (end of study Part A)

Outcome measures

Measure	Part A FAS 1- Olz + Sam 5mg n=52 Participants Subjects who were randomized to olanzapine + samidorphan 5mg in study Part A, received at least one dose of study drug, and had at least one post-baseline assessment of PANSS total score	Part A FAS 1- Olz + Sam 10mg n=59 Participants Subjects who were randomized to olanzapine + samidorphan 10mg in study Part A, received at least one dose of study drug, and had at least one post-baseline assessment of PANSS total score	Part A FAS 1- Olz + Sam 20mg n=54 Participants Subjects who were randomized to olanzapine + samidorphan 20mg in study Part A, received at least one dose of study drug, and had at least one post-baseline assessment of PANSS total score	Part A FAS 2- Olz + Placebo n=35 Participants All FAS 1 subjects who were randomized to olanzapine + placebo in study Part A, gained weight during the first week of olanzapine treatment prior to randomization and had at least one post-baseline weight assessment.	Part A FAS 2- Olz + Sam 5mg n=35 Participants All FAS 1 subjects who were randomized to olanzapine + samidorphan 5mg in study Part A, gained weight during the first week of olanzapine treatment prior to randomization and had at least one post-baseline weight assessment.	Part A FAS 2- Olz + Sam 10mg n=36 Participants Subjects who were randomized to olanzapine + samidorphan 10mg in study Part A, received at least one dose of study drug, and had at least one post-baseline assessment of PANSS total score	Part A FAS 2- Olz + Sam 20mg n=35 Participants Subjects who were randomized to olanzapine + samidorphan 20mg in study Part A, received at least one dose of study drug, and had at least one post-baseline assessment of PANSS total score	Part A FAS 1 - OLZ + Placebo n=56 Participants Subjects who were randomized to olanzapine + placebo in study Part A, received at least one dose of study drug, and had at least one post-baseline assessment of PANSS total score
Percentage of Subjects Exhibiting Significant Weight Gain at Day 92 >=10% weight gain	3 Participants	4 Participants	5 Participants	8 Participants	3 Participants	3 Participants	1 Participants	10 Participants
Percentage of Subjects Exhibiting Significant Weight Gain at Day 92 >= 5% weight gain	18 Participants	16 Participants	16 Participants	14 Participants	13 Participants	8 Participants	8 Participants	20 Participants
Percentage of Subjects Exhibiting Significant Weight Gain at Day 92 >= 7% weight gain	8 Participants	9 Participants	12 Participants	11 Participants	7 Participants	4 Participants	7 Participants	14 Participants

SECONDARY outcome

Timeframe: Baseline (Day 8) to Day 92 (end of study Part A)

Population: Full Analysis Set (FAS) 1 efficacy analysis population included all randomized subjects who received at least one dose of study drug and had at least one postbaseline assessment of Positive and Negative Syndrome Scale (PANSS) total score.

Change in CGI-S score from baseline (Day 8) to the end of Part A (Week 12; Day 92).

The CGI-S is a 7-point scale intended to measure the severity of a patient's illness at the time of assessment. Scores range from 1 (normal) to 7(extremely ill), so a higher score is correlative to more severe illness.

Outcome measures

Measure	Part A FAS 1- Olz + Sam 5mg n=75 Participants Subjects who were randomized to olanzapine + samidorphan 5mg in study Part A, received at least one dose of study drug, and had at least one post-baseline assessment of PANSS total score	Part A FAS 1- Olz + Sam 10mg n=83 Participants Subjects who were randomized to olanzapine + samidorphan 10mg in study Part A, received at least one dose of study drug, and had at least one post-baseline assessment of PANSS total score	Part A FAS 1- Olz + Sam 20mg n=68 Participants Subjects who were randomized to olanzapine + samidorphan 20mg in study Part A, received at least one dose of study drug, and had at least one post-baseline assessment of PANSS total score	Part A FAS 2- Olz + Placebo All FAS 1 subjects who were randomized to olanzapine + placebo in study Part A, gained weight during the first week of olanzapine treatment prior to randomization and had at least one post-baseline weight assessment.	Part A FAS 2- Olz + Sam 5mg All FAS 1 subjects who were randomized to olanzapine + samidorphan 5mg in study Part A, gained weight during the first week of olanzapine treatment prior to randomization and had at least one post-baseline weight assessment.	Part A FAS 2- Olz + Sam 10mg Subjects who were randomized to olanzapine + samidorphan 10mg in study Part A, received at least one dose of study drug, and had at least one post-baseline assessment of PANSS total score	Part A FAS 2- Olz + Sam 20mg Subjects who were randomized to olanzapine + samidorphan 20mg in study Part A, received at least one dose of study drug, and had at least one post-baseline assessment of PANSS total score	Part A FAS 1 - OLZ + Placebo n=74 Participants Subjects who were randomized to olanzapine + placebo in study Part A, received at least one dose of study drug, and had at least one post-baseline assessment of PANSS total score
Change in Clinical Global Impressions - Severity (CGI-S) From Baseline to Day 92	-0.1 units on a scale Standard Error 0.05	-0.0 units on a scale Standard Error 0.05	-0.1 units on a scale Standard Error 0.05	—	—	—	—	-0.0 units on a scale Standard Error 0.05

Adverse Events

Part A- Olz + Placebo

Serious events: 2 serious events

Other events: 33 other events

Deaths: 0 deaths

Part A-Olz + Sam 5mg

Serious events: 3 serious events

Other events: 25 other events

Deaths: 0 deaths

Part A- Olz + Sam 10mg

Serious events: 4 serious events

Other events: 33 other events

Deaths: 0 deaths

Part A- Olz + Sam 20mg

Serious events: 4 serious events

Other events: 33 other events

Deaths: 0 deaths

Part B-Olz +Placebo/ Olz+Sam 20mg

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

Part B- Olz + Sam 5mg / Olz +Sam 5mg

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

Part B- Olz + Sam 10mg/ Olz + Sam 10mg

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

Part B-Olz + Sam 20mg/ Olz + Sam 20mg

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Measure	Part A- Olz + Placebo n=75 participants at risk Olanzapine (dose level determined by Investigator) + placebo tablets taken once daily	Part A-Olz + Sam 5mg n=80 participants at risk Olanzapine (dose level determined by Investigator) + 5mg samidorphan tablets taken once daily	Part A- Olz + Sam 10mg n=86 participants at risk Olanzapine (dose level determined by Investigator) + 10mg Samidorphan tablets taken once daily	Part A- Olz + Sam 20mg n=68 participants at risk Olanzapine (dose level determined by Investigator) + 20mg samidorphan tablets taken once daily	Part B-Olz +Placebo/ Olz+Sam 20mg n=54 participants at risk Olanzapine (dose level determined by Investigator) + 20mg Samidorphan tablets taken once daily Subjects were transitioned from placebo in Part A to 20mg Samidorphan in Part B	Part B- Olz + Sam 5mg / Olz +Sam 5mg n=52 participants at risk Olanzapine (dose level determined by Investigator) + 5mg samidorphan tablets taken once daily	Part B- Olz + Sam 10mg/ Olz + Sam 10mg n=57 participants at risk Olanzapine (dose level determined by Investigator) + 10mg Samidorphan tablets taken once daily	Part B-Olz + Sam 20mg/ Olz + Sam 20mg n=55 participants at risk Olanzapine (dose level determined by Investigator) + 20mg samidorphan tablets taken once daily
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/75 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/80 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	1.2% 1/86 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/68 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/54 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/52 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/57 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/55 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks
Nervous system disorders Ischaemic stroke	1.3% 1/75 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/80 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/86 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/68 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/54 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/52 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/57 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/55 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks
Psychiatric disorders Schizophrenia	1.3% 1/75 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	2.5% 2/80 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	1.2% 1/86 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	4.4% 3/68 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	1.9% 1/54 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/52 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	1.8% 1/57 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/55 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks
Psychiatric disorders Suicidal ideation	0.00% 0/75 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	1.2% 1/80 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/86 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	1.5% 1/68 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/54 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/52 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/57 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/55 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks
Psychiatric disorders Agitation	0.00% 0/75 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/80 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	1.2% 1/86 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/68 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/54 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/52 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/57 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/55 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks
Psychiatric disorders Anxiety	0.00% 0/75 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/80 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	1.2% 1/86 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/68 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/54 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/52 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/57 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/55 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks
Infections and infestations Subcutaneous abscess	0.00% 0/75 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/80 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/86 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/68 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/54 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	1.9% 1/52 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/57 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/55 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks

Other adverse events

Measure	Part A- Olz + Placebo n=75 participants at risk Olanzapine (dose level determined by Investigator) + placebo tablets taken once daily	Part A-Olz + Sam 5mg n=80 participants at risk Olanzapine (dose level determined by Investigator) + 5mg samidorphan tablets taken once daily	Part A- Olz + Sam 10mg n=86 participants at risk Olanzapine (dose level determined by Investigator) + 10mg Samidorphan tablets taken once daily	Part A- Olz + Sam 20mg n=68 participants at risk Olanzapine (dose level determined by Investigator) + 20mg samidorphan tablets taken once daily	Part B-Olz +Placebo/ Olz+Sam 20mg n=54 participants at risk Olanzapine (dose level determined by Investigator) + 20mg Samidorphan tablets taken once daily Subjects were transitioned from placebo in Part A to 20mg Samidorphan in Part B	Part B- Olz + Sam 5mg / Olz +Sam 5mg n=52 participants at risk Olanzapine (dose level determined by Investigator) + 5mg samidorphan tablets taken once daily	Part B- Olz + Sam 10mg/ Olz + Sam 10mg n=57 participants at risk Olanzapine (dose level determined by Investigator) + 10mg Samidorphan tablets taken once daily	Part B-Olz + Sam 20mg/ Olz + Sam 20mg n=55 participants at risk Olanzapine (dose level determined by Investigator) + 20mg samidorphan tablets taken once daily
Investigations Weight increased	12.0% 9/75 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	10.0% 8/80 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	10.5% 9/86 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	8.8% 6/68 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	5.6% 3/54 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	11.5% 6/52 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	3.5% 2/57 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	5.5% 3/55 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks
Investigations Weight decreased	0.00% 0/75 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/80 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/86 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/68 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/54 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/52 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/57 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	5.5% 3/55 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks
Nervous system disorders Somnolence	4.0% 3/75 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	12.5% 10/80 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	12.8% 11/86 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	11.8% 8/68 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	3.7% 2/54 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/52 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	5.3% 3/57 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	7.3% 4/55 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks
Nervous system disorders Sedation	4.0% 3/75 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/80 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	4.7% 4/86 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	11.8% 8/68 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/54 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/52 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/57 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/55 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks
Nervous system disorders Dizziness	1.3% 1/75 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/80 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	3.5% 3/86 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	8.8% 6/68 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/54 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/52 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/57 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/55 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks
Nervous system disorders Headache	5.3% 4/75 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	3.8% 3/80 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	1.2% 1/86 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	1.5% 1/68 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	1.9% 1/54 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/52 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	7.0% 4/57 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	1.8% 1/55 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks
Nervous system disorders Tremor	5.3% 4/75 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/80 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/86 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/68 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/54 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/52 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/57 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/55 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks
Psychiatric disorders Insomnia	5.3% 4/75 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	2.5% 2/80 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	2.3% 2/86 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	1.5% 1/68 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/54 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/52 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/57 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/55 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks
Gastrointestinal disorders Nausea	5.3% 4/75 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	6.2% 5/80 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	4.7% 4/86 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	7.4% 5/68 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	11.1% 6/54 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	1.9% 1/52 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/57 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/55 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks
Gastrointestinal disorders Dry mouth	5.3% 4/75 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	2.5% 2/80 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	5.8% 5/86 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	8.8% 6/68 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/54 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/52 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/57 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/55 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks
Gastrointestinal disorders Constipation	1.3% 1/75 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/80 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	5.8% 5/86 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	2.9% 2/68 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/54 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/52 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/57 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/55 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks
Gastrointestinal disorders Vomiting	0.00% 0/75 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/80 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/86 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/68 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	11.1% 6/54 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/52 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	1.8% 1/57 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/55 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks
Metabolism and nutrition disorders Increased appetite	8.0% 6/75 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	6.2% 5/80 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	5.8% 5/86 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	8.8% 6/68 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/54 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/52 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/57 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/55 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks
Infections and infestations Nasopharyngitis	0.00% 0/75 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/80 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/86 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/68 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/54 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	5.8% 3/52 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	7.0% 4/57 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	3.6% 2/55 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks
Gastrointestinal disorders Toothache	5.3% 4/75 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/80 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/86 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	2.9% 2/68 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/54 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/52 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/57 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks	0.00% 0/55 • Safety assessments are presented for all dosing groups in both Study Parts A and B, i.e. 24 weeks

Additional Information

Director, Corporate and R&D Communications

Alkermes

Phone: 781-609-7000

Email: Gretchen.Murphy@alkermes.com

Results disclosure agreements

• Principal investigator is a sponsor employee Should an Investigator desire to disclose study results, Sponsor will review the results disclosure prior to public release and can embargo the disclosure for a period of at least 60 days. Revisions to the disclosure will be negotiated in good faith. For a multicenter study the Investigators agree to publish/publicly present the results together with the other sites for the 12 month period after study results are available unless Sponsor grants written permission in advance.
• Publication restrictions are in place

Restriction type: OTHER