Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of Risperidone for the Prevention of Mood Episodes in the Treatment of Patients With Bipolar I Disorder (NCT NCT00391222)

NCT ID: NCT00391222

Last Updated: 2014-05-09

Results Overview

Recurrence was estimated using the Kaplan-Meier method and defined as meeting any of the following: DSM-IV-TR criteria for a hypomanic, manic, mixed, or depressive episode; in need of mood stabilizer, antipsychotic medication, benzodiazepine or antidepressant; requiring hospitalization for mood episode; either Young Mania Rating Scale (YMRS) \>12 or Montgomery-Åsberg Depression Rating Scale (MADRS) \>12 combined with Clinical Global Impression - Severity (CGI-S) \>=4; in need of increase in study medication dose or supplementation with oral risperidone or another antipsychotic or mood stabilizer.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 585 participants
• Primary outcome timeframe: Assessed at every visit from the moment of randomization to a treatment arm (baseline Period III) until the end of treatment (Month 21 or earlier)
• Results posted on: 2014-05-09

Participant Flow

This study was run from 14 November 2006 to 13 April 2009. Patients were recruited at 70 investigational sites located in 14 countries across Europe, Asia, Latin-America, and Africa.

Patients were treated appropriately or continued previous treatment. At baseline, treatment with Risperidone Long Acting Injectable (LAI) was started. During 12 weeks patients were stabilized on risperidone LAI and treatment with antipsychotics, mood stabilizers and other psychotropics was titrated off unless otherwise specified in the protocol.

Participant milestones

Measure	Risperidone LAI Double-blind Period III: risperidone long-acting injectable 25, 37.5 or 50 mg intramuscular every 14 days and oral placebo daily	Placebo Double-blind Period III: placebo injections every 14 days and oral placebo daily	Olanzapine Double-blind Period III: placebo injections every 14 days and oral olanzapine daily	Open-label Risperidone LAI Open-label Period II: risperidone long-acting injectable 25, 37.5 or 50 mg intramuscular every 14 days
Period II (Open-label Risperidone LAI) STARTED	0	0	0	560
Period II (Open-label Risperidone LAI) COMPLETED	0	0	0	398
Period II (Open-label Risperidone LAI) NOT COMPLETED	0	0	0	162
Period III (Double-Blind Treatment) STARTED	132	135	131	0
Period III (Double-Blind Treatment) COMPLETED	104	113	108	0
Period III (Double-Blind Treatment) NOT COMPLETED	28	22	23	0

Reasons for withdrawal

Measure	Risperidone LAI Double-blind Period III: risperidone long-acting injectable 25, 37.5 or 50 mg intramuscular every 14 days and oral placebo daily	Placebo Double-blind Period III: placebo injections every 14 days and oral placebo daily	Olanzapine Double-blind Period III: placebo injections every 14 days and oral olanzapine daily	Open-label Risperidone LAI Open-label Period II: risperidone long-acting injectable 25, 37.5 or 50 mg intramuscular every 14 days
Period II (Open-label Risperidone LAI) Withdrawal by Subject	0	0	0	26
Period II (Open-label Risperidone LAI) Lost to Follow-up	0	0	0	5
Period II (Open-label Risperidone LAI) Adverse Event	0	0	0	10
Period II (Open-label Risperidone LAI) Non-responder	0	0	0	97
Period II (Open-label Risperidone LAI) Other	0	0	0	24
Period III (Double-Blind Treatment) Withdrawal by Subject	15	12	6	0
Period III (Double-Blind Treatment) Lost to Follow-up	2	4	4	0
Period III (Double-Blind Treatment) Adverse Event	5	2	4	0
Period III (Double-Blind Treatment) Pregnancy	0	2	0	0
Period III (Double-Blind Treatment) Study Medication Non-compliant	0	1	3	0
Period III (Double-Blind Treatment) Other	6	1	6	0

Baseline Characteristics

A Study to Evaluate the Efficacy and Safety of Risperidone for the Prevention of Mood Episodes in the Treatment of Patients With Bipolar I Disorder

Baseline characteristics by cohort

Measure	Risperidone LAI n=132 Participants Double-blind Period III: risperidone long-acting injectable intramuscular every 14 days and oral placebo daily	Placebo n=135 Participants Double-blind Period III: placebo injections every 14 days and oral placebo daily	Olanzapine n=131 Participants Double-blind Period III: placebo injections every 14 days and oral olanzapine 10 mg/day	Total n=398 Participants Total of all reporting groups
Age, Continuous	35.76 years STANDARD_DEVIATION 11.23 • n=93 Participants	36.87 years STANDARD_DEVIATION 11.08 • n=4 Participants	36.57 years STANDARD_DEVIATION 11.10 • n=27 Participants	36.41 years STANDARD_DEVIATION 11.12 • n=483 Participants
Sex: Female, Male Female	78 Participants n=93 Participants	71 Participants n=4 Participants	59 Participants n=27 Participants	208 Participants n=483 Participants
Sex: Female, Male Male	54 Participants n=93 Participants	64 Participants n=4 Participants	72 Participants n=27 Participants	190 Participants n=483 Participants

PRIMARY outcome

Timeframe: Assessed at every visit from the moment of randomization to a treatment arm (baseline Period III) until the end of treatment (Month 21 or earlier)

Population: ITT analysis set for Period III: all randomized patients who received at least one dose of double-blind study medication and who had at least one post-baseline visit. This excluded 2 patients in both the risperidone LAI arm (discontinued the study due to withdrawal of consent or adverse event) and placebo arm (both withdrew consent).

Recurrence was estimated using the Kaplan-Meier method and defined as meeting any of the following: DSM-IV-TR criteria for a hypomanic, manic, mixed, or depressive episode; in need of mood stabilizer, antipsychotic medication, benzodiazepine or antidepressant; requiring hospitalization for mood episode; either Young Mania Rating Scale (YMRS) >12 or Montgomery-Åsberg Depression Rating Scale (MADRS) >12 combined with Clinical Global Impression - Severity (CGI-S) >=4; in need of increase in study medication dose or supplementation with oral risperidone or another antipsychotic or mood stabilizer.

Outcome measures

Measure	Risperidone LAI n=131 Participants Double-blind Period III: risperidone long-acting injectable 25, 37.5 or 50 mg intramuscular every 14 days and oral placebo daily	Placebo n=133 Participants Double-blind Period III: placebo injections every 14 days and oral placebo daily	Olanzapine Double-blind Period III: placebo injections every 14 days and oral olanzapine daily
Time to Recurrence of a Mood Episode (Risperidone LAI Versus Placebo)	293.39 days Standard Error 15.93	270.47 days Standard Error 17.74 • Interval 171.0 to 354.0	—

SECONDARY outcome

Timeframe: Assessed at every visit from the moment of randomization to a treatment arm (baseline Period III) until the end of treatment (Month 21 or earlier)

Population: ITT analysis set for Period III: all randomized patients who received at least one dose of double-blind study medication and who had at least one post-baseline visit. This excluded 2 patients in both the risperidone LAI arm (discontinued the study due to withdrawal of consent or adverse event) and placebo arm (both withdrew consent).

Recurrences were classified as elevated mood or depressive by the investigator based on the patient's data at the time of the event. Time to recurrence of an elevated mood episode was estimated by means of the same survival analysis method as for the primary outcome.

Outcome measures

Measure	Risperidone LAI n=131 Participants Double-blind Period III: risperidone long-acting injectable 25, 37.5 or 50 mg intramuscular every 14 days and oral placebo daily	Placebo n=133 Participants Double-blind Period III: placebo injections every 14 days and oral placebo daily	Olanzapine n=130 Participants Double-blind Period III: placebo injections every 14 days and oral olanzapine daily
Time to Recurrence of an Elevated Mood (Hypomanic, Manic, or Mixed) Episode	357.41 days Standard Error 13.94	323.14 days Standard Error 18.57	448.03 days Standard Error 12.42

SECONDARY outcome

Timeframe: Assessed at every visit from the moment of randomization to a treatment arm (baseline Period III) until the end of treatment (Month 21 or earlier)

Population: ITT analysis set for Period III: all randomized patients who received at least one dose of double-blind study medication and who had at least one post-baseline visit. This excluded 2 patients in both the risperidone LAI arm (discontinued the study due to withdrawal of consent or adverse event) and placebo arm (both withdrew consent).

Recurrences were classified as elevated mood or depressive by the investigator based on the patient's data at the time of the event. Time to recurrence of a depressive episode was estimated by means of the same survival analysis method as for the primary outcome.

Outcome measures

Measure	Risperidone LAI n=131 Participants Double-blind Period III: risperidone long-acting injectable 25, 37.5 or 50 mg intramuscular every 14 days and oral placebo daily	Placebo n=133 Participants Double-blind Period III: placebo injections every 14 days and oral placebo daily	Olanzapine n=130 Participants Double-blind Period III: placebo injections every 14 days and oral olanzapine daily
Time to Recurrence of a Depressive Episode	213.86 days Standard Error 7.23	300.20 days Standard Error 10.64	356.11 days Standard Error 7.63

SECONDARY outcome

Timeframe: Assessed at every visit from the moment of randomization to a treatment arm (baseline Period III) until the end of treatment (Month 21 or earlier)

Population: ITT analysis set for Period III: all randomized patients who received at least one dose of double-blind study medication and who had at least one post-baseline visit. This excluded 2 patients in both the risperidone LAI arm (discontinued the study due to withdrawal of consent or adverse event) and placebo arm (both withdrew consent).

The robustness of the primary outcome analysis was tested by means of a sensitivity analysis: patients who discontinued the study during Period III for any reason were analyzed as having a recurrence of a mood episode at the time of their study discontinuation. The same survival analysis method as for the primary outcome was applied.

Outcome measures

Measure	Risperidone LAI n=131 Participants Double-blind Period III: risperidone long-acting injectable 25, 37.5 or 50 mg intramuscular every 14 days and oral placebo daily	Placebo n=133 Participants Double-blind Period III: placebo injections every 14 days and oral placebo daily	Olanzapine n=130 Participants Double-blind Period III: placebo injections every 14 days and oral olanzapine daily
Time to Early Study Discontinuation for Any Reason	252.45 days Standard Error 15.87	236.14 days Standard Error 16.02	365.64 days Standard Error 16.16

SECONDARY outcome

Timeframe: Assessed at every visit from the moment of randomization to a treatment arm (baseline Period III) until the end of treatment (Month 21 or earlier)

Population: ITT analysis set for Period III: all randomized patients who received at least one dose of double-blind study medication and who had at least one post-baseline visit. This excluded 2 patients in both the risperidone LAI arm (discontinued the study due to withdrawal of consent or adverse event) and placebo arm (both withdrew consent).

The 11-item YMRS was administered by an adequately trained clinician who did not provide psychotherapy or psycho-education to the patient. A severity rating was assigned to each of the items, based on the patient's subjective report of his or her condition over the previous 7 days or since the last visit (whichever was shorter) and the clinician's behavioral observations during the interview, with emphasis on the latter. The total YMRS score included the score of all 11 items ranging from 0 to 60, a higher score indicating a more severe condition.

Outcome measures

Measure	Risperidone LAI n=131 Participants Double-blind Period III: risperidone long-acting injectable 25, 37.5 or 50 mg intramuscular every 14 days and oral placebo daily	Placebo n=133 Participants Double-blind Period III: placebo injections every 14 days and oral placebo daily	Olanzapine n=130 Participants Double-blind Period III: placebo injections every 14 days and oral olanzapine daily
Change From Double-blind Baseline to Endpoint in Young Mania Rating Scale (YMRS)	2.9 units on a scale Standard Error 0.86	8.0 units on a scale Standard Error 1.16	1.7 units on a scale Standard Error 0.77

SECONDARY outcome

Timeframe: Assessed at every visit from the moment of randomization to a treatment arm (baseline Period III) until the end of treatment (Month 21 or earlier)

Population: ITT analysis set for Period III: all randomized patients who received at least one dose of double-blind study medication and who had at least one post-baseline visit. This excluded 2 patients in both the risperidone LAI arm (discontinued the study due to withdrawal of consent or adverse event) and placebo arm (both withdrew consent).

The MADRS was assessed by an adequately trained clinician who did not provide psychotherapy or psycho-education to the patient. The scale consists of 10 items that cover all of the core depressive symptoms. Each item is scored from 0 to 6 and a total score is calculated by adding the scores of all 10 items. For each individual item as well as for the total score, a higher score represents a more severe condition.

Outcome measures

Measure	Risperidone LAI n=131 Participants Double-blind Period III: risperidone long-acting injectable 25, 37.5 or 50 mg intramuscular every 14 days and oral placebo daily	Placebo n=133 Participants Double-blind Period III: placebo injections every 14 days and oral placebo daily	Olanzapine n=130 Participants Double-blind Period III: placebo injections every 14 days and oral olanzapine daily
Change From Double-blind Baseline to Endpoint in Montgomery Åsberg Depression Rating Scale (MADRS)	5.1 units on a scale Standard Error 0.87	6.1 units on a scale Standard Error 0.99	2.0 units on a scale Standard Error 0.65

SECONDARY outcome

Timeframe: Assessed at every visit from the moment of randomization to a treatment arm (baseline Period III) until the end of treatment (Month 21 or earlier)

Population: ITT analysis set for Period III: all randomized patients who received at least one dose of double-blind study medication and who had at least one post-baseline visit. This excluded 1 patient in the olanzapine arm (discontinued the study due to non-compliance to the study medication).

Recurrence was defined as for the risperidone LAI and placebo arms (meeting any of 5 criteria). Since the study was designed to compare the efficacy of risperidone LAI versus placebo, this olanzapine analysis was exploratory in nature.

Outcome measures

Measure	Risperidone LAI n=130 Participants Double-blind Period III: risperidone long-acting injectable 25, 37.5 or 50 mg intramuscular every 14 days and oral placebo daily	Placebo Double-blind Period III: placebo injections every 14 days and oral placebo daily	Olanzapine Double-blind Period III: placebo injections every 14 days and oral olanzapine daily
Time to Recurrence of a Mood Episode (Exploratory/Olanzapine)	414.04 days Standard Error 14.78	—	—

Adverse Events

Risperidone LAI

Serious events: 19 serious events

Other events: 90 other events

Deaths: 0 deaths

Placebo

Serious events: 32 serious events

Other events: 77 other events

Deaths: 0 deaths

Olanzapine

Serious events: 13 serious events

Other events: 96 other events

Deaths: 0 deaths

Open-label Risperidone LAI

Serious events: 34 serious events

Other events: 326 other events

Deaths: 0 deaths

Serious adverse events

Measure	Risperidone LAI n=132 participants at risk Double-blind Period III: risperidone LAI 25, 37.5 or 50 mg intramuscular every 14 days and oral placebo daily	Placebo n=135 participants at risk Double-blind Period III: placebo injections every 14 days and oral placebo daily	Olanzapine n=131 participants at risk Double-blind Period III: placebo injections every 14 days and oral olanzapine daily	Open-label Risperidone LAI n=560 participants at risk risperidone 25, 37.5, or 50 mg intramuscular every 14 days
Psychiatric disorders Acute stress disorder	0.00% 0/132 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.74% 1/135 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.00% 0/131 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.00% 0/560 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.
Psychiatric disorders Aggression	0.00% 0/132 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.00% 0/135 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.00% 0/131 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.36% 2/560 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.
Psychiatric disorders Agitation	0.76% 1/132 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	1.5% 2/135 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.00% 0/131 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.18% 1/560 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.
Infections and infestations Appendicitis	0.00% 0/132 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.00% 0/135 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.76% 1/131 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.18% 1/560 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.
Psychiatric disorders Bipolar I disorder	1.5% 2/132 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	3.7% 5/135 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.76% 1/131 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.36% 2/560 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.
Respiratory, thoracic and mediastinal disorders Bronchitis chronic	0.00% 0/132 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.00% 0/135 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.00% 0/131 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.18% 1/560 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.
Infections and infestations Bronchopneumonia	0.76% 1/132 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.00% 0/135 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.00% 0/131 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.00% 0/560 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.
Hepatobiliary disorders Cholelithiasis	0.76% 1/132 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.00% 0/135 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.00% 0/131 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.00% 0/560 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.
Cardiac disorders Coronary artery disease	0.00% 0/132 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.00% 0/135 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.76% 1/131 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.00% 0/560 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.
Psychiatric disorders Delusion	0.00% 0/132 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.00% 0/135 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.00% 0/131 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.18% 1/560 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.
Psychiatric disorders Depressed mood	0.76% 1/132 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.74% 1/135 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.00% 0/131 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.00% 0/560 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.
Psychiatric disorders Depression	2.3% 3/132 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	3.0% 4/135 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.76% 1/131 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	1.1% 6/560 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.
Metabolism and nutrition disorders Diabetes mellitus	0.76% 1/132 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.00% 0/135 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.00% 0/131 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.00% 0/560 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.
Metabolism and nutrition disorders Dyslipidaemia	0.00% 0/132 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.00% 0/135 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.76% 1/131 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.00% 0/560 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.
Surgical and medical procedures Female sterilisation	0.00% 0/132 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.00% 0/135 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.00% 0/131 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.18% 1/560 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.
Injury, poisoning and procedural complications Fibula fracture	0.00% 0/132 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	1.5% 2/135 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.00% 0/131 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.00% 0/560 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.
Hepatobiliary disorders Hepatitis	0.00% 0/132 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.00% 0/135 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.00% 0/131 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.18% 1/560 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/132 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.00% 0/135 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.00% 0/131 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.18% 1/560 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.
Vascular disorders Hypertension	0.00% 0/132 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.00% 0/135 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.76% 1/131 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.00% 0/560 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.
Blood and lymphatic system disorders Hypochromic anaemia	0.00% 0/132 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.00% 0/135 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.76% 1/131 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.00% 0/560 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.
Nervous system disorders Hypoglycaemic coma	0.00% 0/132 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.00% 0/135 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.00% 0/131 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.18% 1/560 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.
Psychiatric disorders Hypomania	0.76% 1/132 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.00% 0/135 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.76% 1/131 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.00% 0/560 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.
Psychiatric disorders Insomnia	0.76% 1/132 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.74% 1/135 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.00% 0/131 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.00% 0/560 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.
Injury, poisoning and procedural complications Intentional overdose	0.76% 1/132 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.00% 0/135 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.00% 0/131 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.00% 0/560 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/132 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.00% 0/135 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.00% 0/131 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.18% 1/560 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.
Eye disorders Keratitis	0.00% 0/132 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.00% 0/135 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.00% 0/131 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.18% 1/560 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.
Injury, poisoning and procedural complications Lower limb fracture	0.76% 1/132 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.00% 0/135 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.00% 0/131 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.00% 0/560 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.
Psychiatric disorders Major depression	0.00% 0/132 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.74% 1/135 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.00% 0/131 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.00% 0/560 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.
Psychiatric disorders Mania	4.5% 6/132 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	12.6% 17/135 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	4.6% 6/131 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	2.9% 16/560 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.
Reproductive system and breast disorders Menorrhagia	0.00% 0/132 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.00% 0/135 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.76% 1/131 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.00% 0/560 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.
Injury, poisoning and procedural complications Open fracture	0.00% 0/132 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.00% 0/135 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.00% 0/131 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.18% 1/560 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.
Gastrointestinal disorders Peptic ulcer	0.76% 1/132 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.00% 0/135 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.00% 0/131 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.00% 0/560 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.
Renal and urinary disorders Renal failure acute	0.76% 1/132 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.00% 0/135 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.00% 0/131 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.00% 0/560 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.
Eye disorders Strabismus	0.00% 0/132 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.00% 0/135 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.76% 1/131 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.00% 0/560 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.
Nervous system disorders Subarachnoid haemorrhage	0.00% 0/132 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.00% 0/135 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.00% 0/131 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.18% 1/560 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.
Nervous system disorders Subdural hygroma	0.00% 0/132 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.00% 0/135 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.00% 0/131 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.18% 1/560 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.
Psychiatric disorders Substance abuse	0.00% 0/132 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.00% 0/135 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.76% 1/131 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.00% 0/560 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.
Psychiatric disorders Suicidal ideation	0.00% 0/132 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.74% 1/135 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.00% 0/131 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.54% 3/560 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.
Psychiatric disorders Suicide attempt	1.5% 2/132 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	1.5% 2/135 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.00% 0/131 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.00% 0/560 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.
Injury, poisoning and procedural complications Therapeutic agent toxicity	0.76% 1/132 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.00% 0/135 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.00% 0/131 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.00% 0/560 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/132 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.74% 1/135 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.00% 0/131 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.00% 0/560 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.

Other adverse events

Measure	Risperidone LAI n=132 participants at risk Double-blind Period III: risperidone LAI 25, 37.5 or 50 mg intramuscular every 14 days and oral placebo daily	Placebo n=135 participants at risk Double-blind Period III: placebo injections every 14 days and oral placebo daily	Olanzapine n=131 participants at risk Double-blind Period III: placebo injections every 14 days and oral olanzapine daily	Open-label Risperidone LAI n=560 participants at risk risperidone 25, 37.5, or 50 mg intramuscular every 14 days
Psychiatric disorders Agitation	2.3% 3/132 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	4.4% 6/135 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	4.6% 6/131 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	4.5% 25/560 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.
Nervous system disorders Akathisia	3.8% 5/132 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.74% 1/135 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	4.6% 6/131 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	6.8% 38/560 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.
Reproductive system and breast disorders Amenorrhoea	8.3% 11/132 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	2.2% 3/135 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	2.3% 3/131 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	2.5% 14/560 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.
Psychiatric disorders Anxiety	5.3% 7/132 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	5.2% 7/135 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	4.6% 6/131 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	4.6% 26/560 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.
General disorders Fatigue	3.8% 5/132 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.00% 0/135 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	8.4% 11/131 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	1.8% 10/560 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.
Reproductive system and breast disorders Galactorrhoea	5.3% 7/132 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.00% 0/135 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.00% 0/131 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	2.3% 13/560 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.
Nervous system disorders Headache	1.5% 2/132 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	7.4% 10/135 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	9.2% 12/131 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	6.1% 34/560 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.
Nervous system disorders Hypersomnia	1.5% 2/132 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	3.0% 4/135 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	7.6% 10/131 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.71% 4/560 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.
Metabolism and nutrition disorders Increased appetite	2.3% 3/132 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	1.5% 2/135 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	6.1% 8/131 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	1.6% 9/560 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.
Infections and infestations Influenza	0.76% 1/132 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	6.7% 9/135 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.76% 1/131 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	1.2% 7/560 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.
Psychiatric disorders Insomnia	15.9% 21/132 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	17.8% 24/135 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	9.9% 13/131 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	15.5% 87/560 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.
Gastrointestinal disorders Nausea	0.76% 1/132 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	4.4% 6/135 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	1.5% 2/131 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	0.89% 5/560 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.
Nervous system disorders Somnolence	6.1% 8/132 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	3.0% 4/135 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	12.2% 16/131 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	2.9% 16/560 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.
Nervous system disorders Tremor	3.8% 5/132 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	4.4% 6/135 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	3.8% 5/131 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	5.0% 28/560 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.
Investigations Weight increased	24.2% 32/132 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	8.9% 12/135 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	26.7% 35/131 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.	5.2% 29/560 • AEs were collected from the signing of the informed consent onwards until the last study-related procedure up to 21 months or early discontinuation. The AEs described hereafter are treatment-emergent AEs, defined as having their onset in the specific treatment period in which they were reported and up to 45 days after the last dose of study medication, given the long half-life of risperidone LAI.

Additional Information

EMEA Medical Affairs Director

Janssen Cilag Spain

Phone: +34 91 7228043

Results disclosure agreements

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

Restriction type: GT60