Trial Outcomes & Findings for A Study of Paliperidone Palmitate 6-Month Formulation (NCT NCT03345342)

NCT ID: NCT03345342

Last Updated: 2025-04-29

Results Overview

Time to relapse is time between participant randomization in DB Phase and first documentation of relapse event by end of Month 12 of DB phase. Relapse is defined as: a) Psychiatric hospitalization; b) Positive and Negative Syndrome Scale (PANSS) total score: Increase of 25 percentage (%), 10 point increase in PANSS for 2 analysis separated by 3-7 days if score was greater than (\>) 40, less than or equal to (\<=)40; c) Participants inflicted knowing self-injury/shown violent behavior leading to suicide, clinically significant injury to him/herself or other person/property; d) Participants had suicidal/homicidal ideation/violent behavior that was clinically significant as per investigator; e) PANSS items P1- delusions, P2- conceptual disorganization, P3-hallucinatory behavior, P6- suspiciousness/ persecution, P7-hostility, G8-uncooperativeness: score: greater than or equal to (\>=)5, \>=6 for 2 analysis separated by 3-7 days on any items if maximum score for PANSS: \<=3 or 4, respectively.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 841 participants
• Primary outcome timeframe: Up to 12 months of DB Phase
• Results posted on: 2025-04-29

Participant Flow

Total 841 participants were enrolled, out of which 838 participants received treatment. 2 participants were enrolled but did not receive treatment and 1 participant withdrew from the Open-label Phase and as permitted per the protocol, re-entered the study (under a different participant identifier) and was counted twice in the total. Per the rules specified in statistical analysis plan, only data collected during the second study participation was included in data summary for this participant.

Participant milestones

Measure	Open-Label (OL) PP1M/PP3M Participants previously treated with oral antipsychotics, or injectable risperidone, or a moderate or higher dose of paliperidone palmitate 1-month (PP1M) with previous initiation but without previous stabilization (where stabilization was defined as at least 3 months of injections with the last 2 doses being the same strength) received 1 to 5 intramuscular (IM) injections of PP1M 50 to 150 milligrams equivalent (mg eq.). Participants received single dose of IM injection of PP1M as 100 or 150 mg eq. or PP3M as 350 or 525 mg eq during the OL-maintenance phase.	Double-blind PP3M Participants received 4 doses of PP3M (350 or 525 mg eq. IM injection for up to 12 months (1 dose every 3 month) during DB phase.	Double-blind PP6M Participants received 2 doses of PP6M (700 or 1000 mg eq. IM injection for 12 months (1 dose every 6 months), during the DB Phase. To maintain blinding, participants received IM injections of matching placebo at the 3-month time points between their 6-month doses of PP6M drug.	Follow-up (FU) Phase PP3M Participants who have received at least 1 dose of PP3M (350 or 525 mg eq.) IM injection during double-blind phase but then have relapsed or have met other relevant conditions for withdrawal or discontinuation can participate in the follow-up phase PP3M (350 or 525 mg eq.) IM injection for up to 12 months for evaluating efficacy and safety.	Follow-up Phase PP6M Participants received PP6M (700 or 1000 mg eq.) IM injection for up to 12 months for evaluating efficacy and safety.
Open-Label Phase STARTED	838	0	0	0	0
Open-Label Phase COMPLETED	702	0	0	0	0
Open-Label Phase NOT COMPLETED	136	0	0	0	0
Double-Blind Phase STARTED	0	224	478	0	0
Double-Blind Phase COMPLETED	0	202	416	0	0
Double-Blind Phase NOT COMPLETED	0	22	62	0	0
Follow-Up Phase STARTED	0	0	0	42	109
Follow-Up Phase COMPLETED	0	0	0	34	78
Follow-Up Phase NOT COMPLETED	0	0	0	8	31

Reasons for withdrawal

Measure	Open-Label (OL) PP1M/PP3M Participants previously treated with oral antipsychotics, or injectable risperidone, or a moderate or higher dose of paliperidone palmitate 1-month (PP1M) with previous initiation but without previous stabilization (where stabilization was defined as at least 3 months of injections with the last 2 doses being the same strength) received 1 to 5 intramuscular (IM) injections of PP1M 50 to 150 milligrams equivalent (mg eq.). Participants received single dose of IM injection of PP1M as 100 or 150 mg eq. or PP3M as 350 or 525 mg eq during the OL-maintenance phase.	Double-blind PP3M Participants received 4 doses of PP3M (350 or 525 mg eq. IM injection for up to 12 months (1 dose every 3 month) during DB phase.	Double-blind PP6M Participants received 2 doses of PP6M (700 or 1000 mg eq. IM injection for 12 months (1 dose every 6 months), during the DB Phase. To maintain blinding, participants received IM injections of matching placebo at the 3-month time points between their 6-month doses of PP6M drug.	Follow-up (FU) Phase PP3M Participants who have received at least 1 dose of PP3M (350 or 525 mg eq.) IM injection during double-blind phase but then have relapsed or have met other relevant conditions for withdrawal or discontinuation can participate in the follow-up phase PP3M (350 or 525 mg eq.) IM injection for up to 12 months for evaluating efficacy and safety.	Follow-up Phase PP6M Participants received PP6M (700 or 1000 mg eq.) IM injection for up to 12 months for evaluating efficacy and safety.
Open-Label Phase Adverse Event	30	0	0	0	0
Open-Label Phase Death	1	0	0	0	0
Open-Label Phase Initiated Prohibited Medication	2	0	0	0	0
Open-Label Phase Lack of Efficacy	6	0	0	0	0
Open-Label Phase Lost to Follow-up	9	0	0	0	0
Open-Label Phase Non-Compliance with Study Drug	4	0	0	0	0
Open-Label Phase Physician Decision	4	0	0	0	0
Open-Label Phase Protocol Violation	8	0	0	0	0
Open-Label Phase Withdrawal by Subject	57	0	0	0	0
Open-Label Phase Other	15	0	0	0	0
Double-Blind Phase Adverse Event	0	1	6	0	0
Double-Blind Phase Death	0	2	1	0	0
Double-Blind Phase Initiated Prohibited Medication	0	0	2	0	0
Double-Blind Phase Lost to Follow-up	0	1	7	0	0
Double-Blind Phase Physician Decision	0	1	4	0	0
Double-Blind Phase Protocol Violation	0	0	1	0	0
Double-Blind Phase Withdrawal by Subject	0	16	38	0	0
Double-Blind Phase Other	0	1	3	0	0
Follow-Up Phase Adverse Event	0	0	0	0	4
Follow-Up Phase Lost to Follow-up	0	0	0	0	6
Follow-Up Phase Physician Decision	0	0	0	0	5
Follow-Up Phase Withdrawal by Subject	0	0	0	5	15
Follow-Up Phase Other	0	0	0	3	1

Baseline Characteristics

A Study of Paliperidone Palmitate 6-Month Formulation

Baseline characteristics by cohort

Measure	Open-Label (OL) PP1M/PP3M n=838 Participants Participants previously treated with oral antipsychotics, or injectable risperidone, or a moderate or higher dose of paliperidone palmitate 1-month (PP1M) with previous initiation but without previous stabilization (where stabilization was defined as at least 3 months of injections with the last 2 doses being the same strength) received 1 to 5 intramuscular (IM) injections of PP1M 50 to 150 milligrams equivalent (mg eq.). Participants received single dose of IM injection of PP1M as 100 or 150 mg eq. or PP3M as 350 or 525 mg eq during the OL-maintenance phase.
Age, Continuous	40.8 years STANDARD_DEVIATION 11.68 • n=5 Participants
Sex: Female, Male Female	285 Participants n=5 Participants
Sex: Female, Male Male	553 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	118 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	710 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	10 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	111 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	3 Participants n=5 Participants
Race (NIH/OMB) Black or African American	106 Participants n=5 Participants
Race (NIH/OMB) White	606 Participants n=5 Participants
Race (NIH/OMB) More than one race	5 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants
Region of Enrollment ARGENTINA	55 Participants n=5 Participants
Region of Enrollment AUSTRALIA	4 Participants n=5 Participants
Region of Enrollment BRAZIL	90 Participants n=5 Participants
Region of Enrollment BULGARIA	46 Participants n=5 Participants
Region of Enrollment CZECH REPUBLIC	45 Participants n=5 Participants
Region of Enrollment FRANCE	7 Participants n=5 Participants
Region of Enrollment HONG KONG	4 Participants n=5 Participants
Region of Enrollment HUNGARY	20 Participants n=5 Participants
Region of Enrollment INDIA	42 Participants n=5 Participants
Region of Enrollment ITALY	8 Participants n=5 Participants
Region of Enrollment KOREA, REPUBLIC OF	4 Participants n=5 Participants
Region of Enrollment MALAYSIA	22 Participants n=5 Participants
Region of Enrollment MEXICO	23 Participants n=5 Participants
Region of Enrollment POLAND	68 Participants n=5 Participants
Region of Enrollment RUSSIAN FEDERATION	139 Participants n=5 Participants
Region of Enrollment SPAIN	29 Participants n=5 Participants
Region of Enrollment TAIWAN	31 Participants n=5 Participants
Region of Enrollment TURKEY	26 Participants n=5 Participants
Region of Enrollment UKRAINE	50 Participants n=5 Participants
Region of Enrollment UNITED STATES	125 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 12 months of DB Phase

Population: DB Intent-to-Treat (ITT) analysis set included participants who were randomly assigned to paliperidone palmitate 6-month (PP6M) /paliperidone palmitate 3-month (PP3M) during DB Phase, received at least 1 dose of PP6M/PP3M.

Time to relapse is time between participant randomization in DB Phase and first documentation of relapse event by end of Month 12 of DB phase. Relapse is defined as: a) Psychiatric hospitalization; b) Positive and Negative Syndrome Scale (PANSS) total score: Increase of 25 percentage (%), 10 point increase in PANSS for 2 analysis separated by 3-7 days if score was greater than (>) 40, less than or equal to (<=)40; c) Participants inflicted knowing self-injury/shown violent behavior leading to suicide, clinically significant injury to him/herself or other person/property; d) Participants had suicidal/homicidal ideation/violent behavior that was clinically significant as per investigator; e) PANSS items P1- delusions, P2- conceptual disorganization, P3-hallucinatory behavior, P6- suspiciousness/ persecution, P7-hostility, G8-uncooperativeness: score: greater than or equal to (>=)5, >=6 for 2 analysis separated by 3-7 days on any items if maximum score for PANSS: <=3 or 4, respectively.

Outcome measures

Measure	DB PP3M n=224 Participants Participants received 4 doses of PP3M (350 or 525 milligrams equivalent \[mg eq.\]) intramuscular (IM) injection for up to 12 months (1 dose every 3 month) during DB phase.	DB PP6M n=478 Participants Participants received 2 doses of PP6M (700 or 1000 mg eq.) IM injection for 12 months (1 dose every 6 months), during the DB Phase. To maintain blinding, participants received IM injections of matching placebo at the 3-month time points between their 6-month doses of PP6M drug.
Time to Relapse During the Double-Blind (DB) Phase	NA Days NA indicates that the median, lower and upper limit of confidence interval (CI) was not estimable due to insufficient number of events to determine this value.	NA Days NA indicates that the median, lower and upper limit of confidence interval (CI) was not estimable due to insufficient number of events to determine this value.

SECONDARY outcome

Timeframe: Baseline (DB) to 12 Months of DB Phase

Population: DB ITT analysis set included all participants who were randomly assigned to treatment group of either PP6M or PP3M during the DB Phase and received at least 1 dose of PP6M/PP3M. Here 'N' (number of participants analyzed), signifies participants who were evaluable for this outcome measure.

The neuropsychiatric symptoms of schizophrenia were assessed using the 30-item PANSS scale, which provides a total score (sum of the scores for all 30 items) and scores for 3 subscales: the 7-item positive-symptom (P) subscale, the 7-item negative-symptom (N) subscale, and the 16-item general-psychopathology symptom (G) subscale. Each item is rated on a scale from 1 (absent) to 7 (extreme). The PANSS total score ranges from 30 (absent disease)-210 (more severe neuropsychiatric symptoms of schizophrenia).

Outcome measures

Measure	DB PP3M n=220 Participants Participants received 4 doses of PP3M (350 or 525 milligrams equivalent \[mg eq.\]) intramuscular (IM) injection for up to 12 months (1 dose every 3 month) during DB phase.	DB PP6M n=473 Participants Participants received 2 doses of PP6M (700 or 1000 mg eq.) IM injection for 12 months (1 dose every 6 months), during the DB Phase. To maintain blinding, participants received IM injections of matching placebo at the 3-month time points between their 6-month doses of PP6M drug.
Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score	-1.6 units on a scale Standard Deviation 7.40	-1.8 units on a scale Standard Deviation 8.92

SECONDARY outcome

Timeframe: Baseline (DB) to 12 Months of DB Phase

Population: DB ITT analysis set included all participants who were randomly assigned to treatment group of either PP6M or PP3M during the DB Phase and received at least 1 dose of PP6M/PP3M. Here 'N' (number of participants analyzed), included all participants who were evaluable for this outcome measure.

CGI-S is defined as clinician-rated scale that assesses the severity of mental illness on a scale of 0 to 7. Considering total clinical experience, a participant was assessed on severity of mental illness at the time of rating according to:1: normal, not at all ill; 2: borderline mentally ill; 3: mildly ill; 4: moderately ill; 5: markedly ill; 6: severely ill; 7: among the most extremely ill patients. A higher score implies a more severe condition.

Outcome measures

Measure	DB PP3M n=221 Participants Participants received 4 doses of PP3M (350 or 525 milligrams equivalent \[mg eq.\]) intramuscular (IM) injection for up to 12 months (1 dose every 3 month) during DB phase.	DB PP6M n=475 Participants Participants received 2 doses of PP6M (700 or 1000 mg eq.) IM injection for 12 months (1 dose every 6 months), during the DB Phase. To maintain blinding, participants received IM injections of matching placebo at the 3-month time points between their 6-month doses of PP6M drug.
Change From Baseline in the Clinical Global Impression - Severity (CGI-S) Score	0.0 units on a scale Standard Deviation 0.63	0.0 units on a scale Standard Deviation 0.70

SECONDARY outcome

Timeframe: Baseline (DB) to 12 Months of DB Phase

Population: DB ITT analysis set included all participants who were randomly assigned to treatment group of either PP6M or PP3M during the DB Phase and received at least 1 dose of PP6M/PP3M. Here 'N' (number of participants analyzed), included all participants who were evaluable for this outcome measure.

The Personal and Social Performance (PSP) scale assesses degree of a participant's dysfunction within 4 domains of behavior: 1) socially useful activities, 2) personal and social relationships, 3) self-care, and 4) disturbing and aggressive behavior. Each domain was assessed on a 6-point scale, from 1 (absent) to 6 (very severe) (1 = absent, 2 = mild, 3 = manifest, 4 = marked, 5 = severe, and 6 = very severe). PSP total score was calculated as sum of all the domain scores and ranges from 1 to 100. Participants with score of 71 to 100 have mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision. Higher score indicates better performance.

Outcome measures

Measure	DB PP3M n=220 Participants Participants received 4 doses of PP3M (350 or 525 milligrams equivalent \[mg eq.\]) intramuscular (IM) injection for up to 12 months (1 dose every 3 month) during DB phase.	DB PP6M n=473 Participants Participants received 2 doses of PP6M (700 or 1000 mg eq.) IM injection for 12 months (1 dose every 6 months), during the DB Phase. To maintain blinding, participants received IM injections of matching placebo at the 3-month time points between their 6-month doses of PP6M drug.
Change From Baseline in the Personal and Social Performance (PSP) Scale Total Score	1.1 units on a scale Standard Deviation 8.11	1.0 units on a scale Standard Deviation 7.12

SECONDARY outcome

Timeframe: Up to 12 months of DB Phase

Population: DB ITT included all participants who were randomly assigned to treatment group of either PP6M or PP3M, received at least 1 dose of PP6M/PP3M.

Symptomatic remission was defined as achieving intensity level of mild or moderate on PANSS scale by all 8 items as the determinants for symptomatic remission: delusions, unusual thought content, hallucinatory behavior, conceptual disorganization, mannerisms/posturing, blunted affect, social withdrawal, lack of spontaneity. The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self). The PANSS provides a total score and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each item scored on a scale of 1 (absent), 2 (minimal), 3 (mild), 4 (moderate), 5 (moderately severe), 6 (severe) and 7 (extreme). The total score ranges from 30 to 210 and higher score indicates greater severity.

Outcome measures

Measure	DB PP3M n=224 Participants Participants received 4 doses of PP3M (350 or 525 milligrams equivalent \[mg eq.\]) intramuscular (IM) injection for up to 12 months (1 dose every 3 month) during DB phase.	DB PP6M n=478 Participants Participants received 2 doses of PP6M (700 or 1000 mg eq.) IM injection for 12 months (1 dose every 6 months), during the DB Phase. To maintain blinding, participants received IM injections of matching placebo at the 3-month time points between their 6-month doses of PP6M drug.
Percentage of Participants With Symptomatic Remission Based on PANSS Score During DB Phase	70.1 Percentage of participants	66.3 Percentage of participants

SECONDARY outcome

Timeframe: Baseline (DB) to 12 Months of DB Phase

Population: DB ITT analysis set included all participants who were randomly assigned to treatment group of either PP6M or PP3M during the DB Phase and received at least 1 dose of PP6M/PP3M. Here 'N' (number of participants analyzed), included all participants who were evaluable for this outcome measure.

The SPSR Short Form 8a is a participant-reported outcome used to assess the satisfaction with participation in social roles. The participants were asked to rate 8 items on 5-point Likert scale, with scores ranging from 8 to 40, where higher scores represents higher satisfaction.

Outcome measures

Measure	DB PP3M n=70 Participants Participants received 4 doses of PP3M (350 or 525 milligrams equivalent \[mg eq.\]) intramuscular (IM) injection for up to 12 months (1 dose every 3 month) during DB phase.	DB PP6M n=154 Participants Participants received 2 doses of PP6M (700 or 1000 mg eq.) IM injection for 12 months (1 dose every 6 months), during the DB Phase. To maintain blinding, participants received IM injections of matching placebo at the 3-month time points between their 6-month doses of PP6M drug.
Change From Baseline in the Satisfaction With Participants in Social Roles (SPSR) Score	0.9 units on a scale Standard Deviation 7.15	0.6 units on a scale Standard Deviation 6.58

SECONDARY outcome

Timeframe: Baseline (DB) to 12 Months of DB Phase

Population: DB ITT analysis set included all participants who were randomly assigned to treatment group of either PP6M or PP3M during the DB Phase and received at least 1 dose of PP6M/PP3M. Here 'N' (number of participants analyzed), included all participants who were evaluable for this outcome measure.

TSQM-9 consists of 9 questions to assess patients' satisfaction with medication using a range of responses from 1 (extremely dissatisfied) to (7 extremely satisfied). This patient reported outcome provides scores on three parts: effectiveness, convenience, and global satisfaction. The sum of the 9-questions were calculated and used for analysis. The total score ranges from 0 to 63, with higher scores indicating better treatment satisfaction.

Outcome measures

Measure	DB PP3M n=121 Participants Participants received 4 doses of PP3M (350 or 525 milligrams equivalent \[mg eq.\]) intramuscular (IM) injection for up to 12 months (1 dose every 3 month) during DB phase.	DB PP6M n=279 Participants Participants received 2 doses of PP6M (700 or 1000 mg eq.) IM injection for 12 months (1 dose every 6 months), during the DB Phase. To maintain blinding, participants received IM injections of matching placebo at the 3-month time points between their 6-month doses of PP6M drug.
Change From Baseline in the Treatment Satisfaction Questionnaire for Medication (TSQM-9) Total Score Overall satisfaction	2.5 units on a scale Standard Deviation 19.29	0.5 units on a scale Standard Deviation 20.02
Change From Baseline in the Treatment Satisfaction Questionnaire for Medication (TSQM-9) Total Score Effectiveness	6.0 units on a scale Standard Deviation 21.18	3.6 units on a scale Standard Deviation 19.49
Change From Baseline in the Treatment Satisfaction Questionnaire for Medication (TSQM-9) Total Score Convenience	3.4 units on a scale Standard Deviation 17.76	1.1 units on a scale Standard Deviation 15.30

SECONDARY outcome

Timeframe: Baseline (DB) to 12 Months of DB Phase

Population: DB ITT analysis set included all participants who were randomly assigned to treatment group of either PP6M or PP3M during the DB Phase and received at least 1 dose of PP6M/PP3M. Here 'N' (number of participants analyzed), included all participants who were evaluable for this outcome measure.

The SAS rates 10 items for general extrapyramidal symptoms (EPS) on a 5-point scale from 0 (normal) to 4 (extreme), including gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, leg pendulousness, head rotation, Glabellar tap, tremor, and salivation. The SAS total score is the average score (total sum of item scores divided by the number of items) and ranges between 0 and 4. Negative change in score indicates improvement. Higher scores denote more severe condition of EPS.

Outcome measures

Measure	DB PP3M n=220 Participants Participants received 4 doses of PP3M (350 or 525 milligrams equivalent \[mg eq.\]) intramuscular (IM) injection for up to 12 months (1 dose every 3 month) during DB phase.	DB PP6M n=477 Participants Participants received 2 doses of PP6M (700 or 1000 mg eq.) IM injection for 12 months (1 dose every 6 months), during the DB Phase. To maintain blinding, participants received IM injections of matching placebo at the 3-month time points between their 6-month doses of PP6M drug.
Change From Baseline in the Simpson-Angus Rating Scale (SAS) Total Score	0.00 units on a scale Interval -0.6 to 2.1	0.00 units on a scale Interval -0.6 to 1.5

SECONDARY outcome

Timeframe: Up to 12 Months of DB Phase

Population: DB ITT analysis set included all participants who were randomly assigned to treatment group of either PP6M or PP3M during the DB Phase and received at least 1 dose of PP6M/PP3M.

BARS is used to rate observable, restless movements of drug induced akathisia and subjective awareness of restlessness and any distress associated with the akathisia. BARS consists of the following 4 items: objective assessment of akathisia symptoms, subjective assessment of the participants's awareness of inner restlessness, distress restlessness, and global clinical assessment of akathisia. First three items are rated on a 4-point scale ranging from 0 (no abnormal movements or absence of inner restlessness or no distress) to 3 (severe akathisia or awareness of intense compulsion to move most of the time or severe distress). The last item, the global clinical assessment of akathisia, is rated on a 6-point scale, ranging from 0 (no evidence of akathisia) to 5 (severe akathisia).

Outcome measures

Measure	DB PP3M n=224 Participants Participants received 4 doses of PP3M (350 or 525 milligrams equivalent \[mg eq.\]) intramuscular (IM) injection for up to 12 months (1 dose every 3 month) during DB phase.	DB PP6M n=478 Participants Participants received 2 doses of PP6M (700 or 1000 mg eq.) IM injection for 12 months (1 dose every 6 months), during the DB Phase. To maintain blinding, participants received IM injections of matching placebo at the 3-month time points between their 6-month doses of PP6M drug.
Number of Participants With Symptoms of Akathisia Assessed Using Barnes Akathisia Rating Scale (BARS) Score Global Clinical Assessment	185 Participants	380 Participants
Number of Participants With Symptoms of Akathisia Assessed Using Barnes Akathisia Rating Scale (BARS) Score Objective	185 Participants	380 Participants
Number of Participants With Symptoms of Akathisia Assessed Using Barnes Akathisia Rating Scale (BARS) Score Subjective (Awareness)	185 Participants	380 Participants
Number of Participants With Symptoms of Akathisia Assessed Using Barnes Akathisia Rating Scale (BARS) Score Subjective (Distress)	185 Participants	380 Participants

SECONDARY outcome

Timeframe: Baseline (DB) to 12 Months of DB Phase

Population: DB ITT analysis set included all participants who were randomly assigned to treatment group of either PP6M or PP3M during the DB Phase and received at least 1 dose of PP6M/PP3M. Here 'N' (number of participants analyzed), included all participants who were evaluable for this outcome measure.

AIMS is a 14-item scale. Items 1 to 8 are rated on a 5-point scale ranging from 0 (no dyskinetic movements) to 4 (severe dyskinetic movements). Item 9 assesses the participant's incapacitation due to abnormal movements, and item 10 assesses the participant's awareness of the abnormal movements and associated distress. Items 9 and 10 are rated on 5-point scales ranging from 0 (none or no awareness) to 4 (severe or aware, severe distress). Items 11 to 14 are yes/no questions regarding the global judgement and dental status of the participant. The total score is the sum of the scores for the 14 items and the possible total score ranges from 0 to 44. A higher total score is indicative of more severe dyskinetic movements.

Outcome measures

Measure	DB PP3M n=221 Participants Participants received 4 doses of PP3M (350 or 525 milligrams equivalent \[mg eq.\]) intramuscular (IM) injection for up to 12 months (1 dose every 3 month) during DB phase.	DB PP6M n=477 Participants Participants received 2 doses of PP6M (700 or 1000 mg eq.) IM injection for 12 months (1 dose every 6 months), during the DB Phase. To maintain blinding, participants received IM injections of matching placebo at the 3-month time points between their 6-month doses of PP6M drug.
Change From Baseline in the Abnormal Involuntary Movement Scale (AIMS) Total Score	0.0 units on a scale Interval -3.0 to 2.0	0.0 units on a scale Interval -7.0 to 14.0

SECONDARY outcome

Timeframe: Baseline and endpoint (12 Months of DB Phase)

Population: DB ITT analysis set included all participants who were randomly assigned to treatment group of either PP6M or PP3M during the DB Phase and received at least 1 dose of PP6M/PP3M. Here 'n' (number analyzed) included all evaluable participants who were analyzed for specified categories.

The C-SSRS is a questionnaire used for suicide risk assessment. Affirmative or negative responses are provided to items 1 to 5 for suicidal ideation (1. Wish to be dead, 2. Non-specific active suicidal thoughts, 3. Active suicidal ideation with any methods [not plan] without intent to act, 4. Active suicidal ideation with some intent to act, without specific plan, 5. Active suicidal ideation with specific plan and intent) and items 6 to 10 for suicide behavior (6. Preparatory acts or behavior, 7. Aborted attempt, 8. Interrupted attempt, 9. Actual attempt, 10. Completed suicide). Total score ranges from 1 to 10. Higher scores indicate more severe suicidal ideation.

Outcome measures

Measure	DB PP3M n=224 Participants Participants received 4 doses of PP3M (350 or 525 milligrams equivalent \[mg eq.\]) intramuscular (IM) injection for up to 12 months (1 dose every 3 month) during DB phase.	DB PP6M n=478 Participants Participants received 2 doses of PP6M (700 or 1000 mg eq.) IM injection for 12 months (1 dose every 6 months), during the DB Phase. To maintain blinding, participants received IM injections of matching placebo at the 3-month time points between their 6-month doses of PP6M drug.
Number of Participants Based on Columbia Suicide Severity Rating Scale (C-SSRS) Total Score Baseline (0= No event)	221 Participants	477 Participants
Number of Participants Based on Columbia Suicide Severity Rating Scale (C-SSRS) Total Score Baseline (1= Wish to be dead)	3 Participants	0 Participants
Number of Participants Based on Columbia Suicide Severity Rating Scale (C-SSRS) Total Score Baseline (2= Non-specific suicidal thought)	0 Participants	1 Participants
Number of Participants Based on Columbia Suicide Severity Rating Scale (C-SSRS) Total Score Baseline (3= Suicidal ideation-no intent)	0 Participants	0 Participants
Number of Participants Based on Columbia Suicide Severity Rating Scale (C-SSRS) Total Score Baseline (4= Ideation with intent, no plan)	0 Participants	0 Participants
Number of Participants Based on Columbia Suicide Severity Rating Scale (C-SSRS) Total Score Baseline (5= Ideation with plan/intent)	0 Participants	0 Participants
Number of Participants Based on Columbia Suicide Severity Rating Scale (C-SSRS) Total Score Baseline (6= Preparatory acts/behavior)	0 Participants	0 Participants
Number of Participants Based on Columbia Suicide Severity Rating Scale (C-SSRS) Total Score Baseline (7= Aborted attempt)	0 Participants	0 Participants
Number of Participants Based on Columbia Suicide Severity Rating Scale (C-SSRS) Total Score Baseline (8= Interrupted attempt)	0 Participants	0 Participants
Number of Participants Based on Columbia Suicide Severity Rating Scale (C-SSRS) Total Score Baseline (9= Actual attempt)	0 Participants	0 Participants
Number of Participants Based on Columbia Suicide Severity Rating Scale (C-SSRS) Total Score Baseline (10= Suicide)	0 Participants	0 Participants
Number of Participants Based on Columbia Suicide Severity Rating Scale (C-SSRS) Total Score End Point (0= No event)	218 Participants	471 Participants
Number of Participants Based on Columbia Suicide Severity Rating Scale (C-SSRS) Total Score End Point (1= Wish to be dead)	1 Participants	1 Participants
Number of Participants Based on Columbia Suicide Severity Rating Scale (C-SSRS) Total Score End Point (2= Non-specific suicidal thought)	0 Participants	0 Participants
Number of Participants Based on Columbia Suicide Severity Rating Scale (C-SSRS) Total Score End Point (3= Suicidal ideation-no intent)	0 Participants	1 Participants
Number of Participants Based on Columbia Suicide Severity Rating Scale (C-SSRS) Total Score End Point (4= Ideation with intent, no plan)	1 Participants	0 Participants
Number of Participants Based on Columbia Suicide Severity Rating Scale (C-SSRS) Total Score End Point (5= Ideation with plan/intent)	1 Participants	2 Participants
Number of Participants Based on Columbia Suicide Severity Rating Scale (C-SSRS) Total Score End Point (6= Preparatory acts/behavior)	0 Participants	0 Participants
Number of Participants Based on Columbia Suicide Severity Rating Scale (C-SSRS) Total Score End Point (7= Aborted attempt)	0 Participants	0 Participants
Number of Participants Based on Columbia Suicide Severity Rating Scale (C-SSRS) Total Score End Point (8= Interrupted attempt)	0 Participants	0 Participants
Number of Participants Based on Columbia Suicide Severity Rating Scale (C-SSRS) Total Score End Point (9= Actual attempt)	0 Participants	1 Participants
Number of Participants Based on Columbia Suicide Severity Rating Scale (C-SSRS) Total Score End Point (10= Suicide)	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline (DB) to 12 Months of DB Phase

Population: Double-blind safety analysis set (DB safety) included all participants who were randomly assigned to treatment group of either PP6M or PP3M during the DB Phase and received at least 1 dose of PP6M/PP3M. Here 'N' (number of participants analyzed), included all participants who were evaluable for this outcome measure.

Number of participants with treatment-emergent abnormal ECG values were reported. It includes heart rate (abnormally low refers to less than or equal to [<=] 50 beats per minute (bpm) , abnormally high refers greater than or equal to [>=] 100 bpm), pulse rate (PR) interval (abnormally high refers to >= 210 milliseconds [msec]), QRS interval (abnormally Low refers to <= 50, abnormally high refers to >= 120 msec) and QT interval (abnormally low refers to <= 200, abnormally high >= 500 msec).

Outcome measures

Measure	DB PP3M n=220 Participants Participants received 4 doses of PP3M (350 or 525 milligrams equivalent \[mg eq.\]) intramuscular (IM) injection for up to 12 months (1 dose every 3 month) during DB phase.	DB PP6M n=474 Participants Participants received 2 doses of PP6M (700 or 1000 mg eq.) IM injection for 12 months (1 dose every 6 months), during the DB Phase. To maintain blinding, participants received IM injections of matching placebo at the 3-month time points between their 6-month doses of PP6M drug.
Number of Participants With Treatment-emergent Abnormal Electrocardiogram (ECG) Values During DB Phase Heart Rate value <=50	5 Participants	9 Participants
Number of Participants With Treatment-emergent Abnormal Electrocardiogram (ECG) Values During DB Phase Heart Rate value >=100	20 Participants	36 Participants
Number of Participants With Treatment-emergent Abnormal Electrocardiogram (ECG) Values During DB Phase PR Duration value >= 210	3 Participants	8 Participants
Number of Participants With Treatment-emergent Abnormal Electrocardiogram (ECG) Values During DB Phase QRS Duration value <= 50	0 Participants	0 Participants
Number of Participants With Treatment-emergent Abnormal Electrocardiogram (ECG) Values During DB Phase QRS Duration value >= 120	1 Participants	2 Participants
Number of Participants With Treatment-emergent Abnormal Electrocardiogram (ECG) Values During DB Phase QT Duration value <= 200	0 Participants	0 Participants
Number of Participants With Treatment-emergent Abnormal Electrocardiogram (ECG) Values During DB Phase QT Duration value >= 500	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline (DB) to 12 Months of DB Phase

Population: DB ITT analysis set included all participants who were randomly assigned to treatment group of either PP6M or PP3M during the DB Phase and received at least 1 dose of PP6M/PP3M. Here 'N' (number of participants analyzed), included all participants who were evaluable for this outcome measure.

Change from baseline in BMI was reported.

Outcome measures

Measure	DB PP3M n=219 Participants Participants received 4 doses of PP3M (350 or 525 milligrams equivalent \[mg eq.\]) intramuscular (IM) injection for up to 12 months (1 dose every 3 month) during DB phase.	DB PP6M n=473 Participants Participants received 2 doses of PP6M (700 or 1000 mg eq.) IM injection for 12 months (1 dose every 6 months), during the DB Phase. To maintain blinding, participants received IM injections of matching placebo at the 3-month time points between their 6-month doses of PP6M drug.
Change From Baseline in the Body Mass Index (BMI) During DB Phase	0.3 kilogram per meter square (kg/m^2) Standard Deviation 1.78	0.0 kilogram per meter square (kg/m^2) Standard Deviation 1.72

SECONDARY outcome

Timeframe: Baseline (DB) to 12 Months of DB Phase

Population: DB ITT analysis set included all participants who were randomly assigned to treatment group of either PP6M or PP3M during the DB Phase and received at least 1 dose of PP6M/PP3M. Here 'N' (number of participants analyzed), included all participants who were evaluable for this outcome measure.

Change from baseline in waist circumference was reported.

Outcome measures

Measure	DB PP3M n=219 Participants Participants received 4 doses of PP3M (350 or 525 milligrams equivalent \[mg eq.\]) intramuscular (IM) injection for up to 12 months (1 dose every 3 month) during DB phase.	DB PP6M n=473 Participants Participants received 2 doses of PP6M (700 or 1000 mg eq.) IM injection for 12 months (1 dose every 6 months), during the DB Phase. To maintain blinding, participants received IM injections of matching placebo at the 3-month time points between their 6-month doses of PP6M drug.
Change From Baseline in the Waist Circumference During DB Phase	0.82 centimeter (cm) Standard Deviation 5.137	0.37 centimeter (cm) Standard Deviation 5.157

SECONDARY outcome

Timeframe: Baseline (DB) to 12 Months of DB Phase

Population: DB ITT analysis set included all participants who were randomly assigned to treatment group of either PP6M or PP3M during the DB Phase and received at least 1 dose of PP6M/PP3M. Here 'N' (number of participants analyzed), included all participants who were evaluable for this outcome measure.

Change from baseline in body weight was reported.

Outcome measures

Measure	DB PP3M n=219 Participants Participants received 4 doses of PP3M (350 or 525 milligrams equivalent \[mg eq.\]) intramuscular (IM) injection for up to 12 months (1 dose every 3 month) during DB phase.	DB PP6M n=473 Participants Participants received 2 doses of PP6M (700 or 1000 mg eq.) IM injection for 12 months (1 dose every 6 months), during the DB Phase. To maintain blinding, participants received IM injections of matching placebo at the 3-month time points between their 6-month doses of PP6M drug.
Change From Baseline in the Body Weight During DB Phase	0.96 kilogram (kg) Standard Deviation 5.103	0.10 kilogram (kg) Standard Deviation 4.959

SECONDARY outcome

Timeframe: Baseline (DB) to 12 Months of DB Phase

Population: DB ITT analysis set included all participants who were randomly assigned to treatment group of either PP6M or PP3M during the DB Phase and received at least 1 dose of PP6M/PP3M. Here 'N' (number of participants analyzed), included all participants who were evaluable for this outcome measure.

Change from baseline vital signs (pulse rate) were reported. This included supine pulse rate, standing pulse rate and supine-standing pulse rate.

Outcome measures

Measure	DB PP3M n=219 Participants Participants received 4 doses of PP3M (350 or 525 milligrams equivalent \[mg eq.\]) intramuscular (IM) injection for up to 12 months (1 dose every 3 month) during DB phase.	DB PP6M n=473 Participants Participants received 2 doses of PP6M (700 or 1000 mg eq.) IM injection for 12 months (1 dose every 6 months), during the DB Phase. To maintain blinding, participants received IM injections of matching placebo at the 3-month time points between their 6-month doses of PP6M drug.
Change From Baseline in the Vital Signs (Pulse Rate) During DB Phase Supine Pulse Rate	1.2 beats per minute (bpm) Standard Deviation 11.57	0.6 beats per minute (bpm) Standard Deviation 11.56
Change From Baseline in the Vital Signs (Pulse Rate) During DB Phase Standing Pulse Rate	2.6 beats per minute (bpm) Standard Deviation 12.28	0.9 beats per minute (bpm) Standard Deviation 12.60
Change From Baseline in the Vital Signs (Pulse Rate) During DB Phase Pulse Rate (Standing-Supine)	1.5 beats per minute (bpm) Standard Deviation 8.85	0.2 beats per minute (bpm) Standard Deviation 8.31

SECONDARY outcome

Timeframe: Baseline (DB) to 12 Months of DB Phase

Population: DB ITT analysis set included all participants who were randomly assigned to treatment group of either PP6M or PP3M during the DB Phase and received at least 1 dose of PP6M/PP3M. Here 'N' (number of participants analyzed), included all participants who were evaluable for this outcome measure.

Change from baseline in vital signs including SBP and DBP (supine/standing) were reported.

Outcome measures

Measure	DB PP3M n=219 Participants Participants received 4 doses of PP3M (350 or 525 milligrams equivalent \[mg eq.\]) intramuscular (IM) injection for up to 12 months (1 dose every 3 month) during DB phase.	DB PP6M n=473 Participants Participants received 2 doses of PP6M (700 or 1000 mg eq.) IM injection for 12 months (1 dose every 6 months), during the DB Phase. To maintain blinding, participants received IM injections of matching placebo at the 3-month time points between their 6-month doses of PP6M drug.
Change From Baseline in the Vital Signs (Systolic Blood Pressure [SBP] and Diastolic Blood Pressure [DBP]) During DB Phase Supine DBP	0.1 millimetre of mercury (mmHg) Standard Deviation 9.25	-0.4 millimetre of mercury (mmHg) Standard Deviation 7.49
Change From Baseline in the Vital Signs (Systolic Blood Pressure [SBP] and Diastolic Blood Pressure [DBP]) During DB Phase Standing DBP	0.3 millimetre of mercury (mmHg) Standard Deviation 9.39	0.4 millimetre of mercury (mmHg) Standard Deviation 7.48
Change From Baseline in the Vital Signs (Systolic Blood Pressure [SBP] and Diastolic Blood Pressure [DBP]) During DB Phase DBP (Standing-Supine)	0.2 millimetre of mercury (mmHg) Standard Deviation 7.79	0.7 millimetre of mercury (mmHg) Standard Deviation 6.43
Change From Baseline in the Vital Signs (Systolic Blood Pressure [SBP] and Diastolic Blood Pressure [DBP]) During DB Phase Supine SBP	-0.3 millimetre of mercury (mmHg) Standard Deviation 13.14	0.6 millimetre of mercury (mmHg) Standard Deviation 9.96
Change From Baseline in the Vital Signs (Systolic Blood Pressure [SBP] and Diastolic Blood Pressure [DBP]) During DB Phase Standing SBP	0.8 millimetre of mercury (mmHg) Standard Deviation 12.08	1.3 millimetre of mercury (mmHg) Standard Deviation 10.40
Change From Baseline in the Vital Signs (Systolic Blood Pressure [SBP] and Diastolic Blood Pressure [DBP]) During DB Phase SBP (Standing-Supine)	1.0 millimetre of mercury (mmHg) Standard Deviation 9.83	0.6 millimetre of mercury (mmHg) Standard Deviation 7.32

SECONDARY outcome

Timeframe: Baseline (DB) to 12 Months of DB Phase

Population: DB ITT analysis set included all participants who were randomly assigned to treatment group of either PP6M or PP3M during the DB Phase and received at least 1 dose of PP6M/PP3M. Here 'N' (number of participants analyzed), included all participants who were evaluable for this outcome measure.

The neuropsychiatric symptoms of schizophrenia were assessed using the 30-item PANSS scale, which provides a total score (sum of the scores for all 30 items) and Scores for 3 subscales, that is, for positive subscale (sum of the scores of all 7 items) and negative subscale (sum of the scores of all 7 items) ranges from 7 (absent) to 49 (extreme psychopathology), and for the general psychopathology subscale (sum of the scores of all 16 items) score ranges from 16 (absent) to 112 (extreme psychopathology).

Outcome measures

Measure	DB PP3M n=220 Participants Participants received 4 doses of PP3M (350 or 525 milligrams equivalent \[mg eq.\]) intramuscular (IM) injection for up to 12 months (1 dose every 3 month) during DB phase.	DB PP6M n=473 Participants Participants received 2 doses of PP6M (700 or 1000 mg eq.) IM injection for 12 months (1 dose every 6 months), during the DB Phase. To maintain blinding, participants received IM injections of matching placebo at the 3-month time points between their 6-month doses of PP6M drug.
Change From Baseline in Positive and Syndrome Scale (PANSS) Subscales Score During DB Phase Positive Subscale Score	-0.1 units on a scale Standard Deviation 2.82	-0.1 units on a scale Standard Deviation 3.30
Change From Baseline in Positive and Syndrome Scale (PANSS) Subscales Score During DB Phase Negative Subscale Score	-0.6 units on a scale Standard Deviation 2.61	-0.7 units on a scale Standard Deviation 2.70
Change From Baseline in Positive and Syndrome Scale (PANSS) Subscales Score During DB Phase General Psychopathology Subscale Score	-0.9 units on a scale Standard Deviation 4.18	-1.0 units on a scale Standard Deviation 4.86

SECONDARY outcome

Timeframe: Up to 12 Months of DB Phase

Population: Double-Blind safety analysis set (DB safety) included all participants who were randomly assigned to treatment group of either PP6M or PP3M during the DB Phase and received at least 1 dose of PP6M/PP3M. Here 'N' (number of participants analyzed), included all participants who were evaluable for this outcome measure. Here 'n' (number analyzed) included all evaluable participants who were analyzed for specified categories.

Number of participants with clinically significant abnormal laboratory values in chemistry included alanine aminotransferase (Unit per Litre [U/L]), albumin (Gram per Litre [g/L]), alkaline phosphatase (U/L), aspartate aminotransferase (U/L), bicarbonate (millimoles per litre [mmol/L]), bilirubin (micromoles per litre [umol/L]), calcium (mmol/L), chloride (mmol/L), cholesterol (mmol/L), creatinine (umol/L), gamma glutamyl transferase (GGT) (U/L), glucose (mmol/L), high-density lipoproteins (HDL) cholesterol (mmol/L), low density lipoproteins (LDL) cholesterol (mmol/L), lactate dehydrogenase (U/L), phosphate (mmol/L), potassium (mmol/L), protein (mmol/L), sodium (mmol/L), triglycerides (mmol/L), urate (umol/L), urea nitrogen (mmol/L) were reported. Here, ABL signifies abnormally low and ABH signifies abnormally high levels.

Outcome measures

Measure	DB PP3M n=216 Participants Participants received 4 doses of PP3M (350 or 525 milligrams equivalent \[mg eq.\]) intramuscular (IM) injection for up to 12 months (1 dose every 3 month) during DB phase.	DB PP6M n=464 Participants Participants received 2 doses of PP6M (700 or 1000 mg eq.) IM injection for 12 months (1 dose every 6 months), during the DB Phase. To maintain blinding, participants received IM injections of matching placebo at the 3-month time points between their 6-month doses of PP6M drug.
Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase Chloride ABL	4 Participants	5 Participants
Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase Glucose ABL	1 Participants	0 Participants
Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase HDL Cholesterol ABL	18 Participants	40 Participants
Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase Lactate Dehydrogenase ABH	0 Participants	1 Participants
Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase Alanine Aminotransferase ABH	0 Participants	1 Participants
Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase Albumin ABL	0 Participants	0 Participants
Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase Albumin ABH	0 Participants	0 Participants
Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase Alkaline Phosphatase ABH	0 Participants	0 Participants
Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase Aspartate Aminotransferase ABH	0 Participants	0 Participants
Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase Bicarbonate ABL	0 Participants	3 Participants
Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase Bicarbonate ABH	0 Participants	0 Participants
Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase Bilirubin ABH	0 Participants	1 Participants
Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase Calcium ABL	0 Participants	0 Participants
Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase Calcium ABH	0 Participants	0 Participants
Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase Chloride ABH	0 Participants	0 Participants
Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase Cholesterol ABH	2 Participants	4 Participants
Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase Creatinine ABH	0 Participants	0 Participants
Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase Gamma Glutamyl Transferase ABH	0 Participants	2 Participants
Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase Glucose ABH	1 Participants	5 Participants
Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase LDL Cholesterol ABL	33 Participants	44 Participants
Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase LDL Cholesterol ABH	9 Participants	22 Participants
Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase Phosphate ABL	1 Participants	8 Participants
Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase Phosphate ABH	0 Participants	0 Participants
Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase Potassium ABL	0 Participants	0 Participants
Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase Potassium ABH	0 Participants	0 Participants
Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase Protein ABL	0 Participants	1 Participants
Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase Sodium ABL	1 Participants	0 Participants
Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase Sodium ABH	0 Participants	0 Participants
Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase Triglycerides ABH	4 Participants	6 Participants
Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase Urate ABL	0 Participants	0 Participants
Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase Urate ABH	1 Participants	4 Participants
Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase Urea Nitrogen ABH	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 12 Months of DB Phase

Population: Double-blind safety analysis set (DB safety) included all participants who were randomly assigned to treatment group of either PP6M or PP3M during the DB Phase and received at least 1 dose of PP6M/PP3M. Here 'N' (number of participants analyzed), included all participants who were evaluable for this outcome measure. Here 'n' (number analyzed) included all evaluable participants who were analyzed for specified categories.

Number of participants with clinically significant abnormal laboratory values in hematology included hemoglobin (Hb), hematocrit (Hct), red blood cell (RBC) count, white blood cell (WBC) count with differential, platelets, hemoglobin A1c. Here, ABL signifies abnormally low and ABH signifies abnormally high levels.

Outcome measures

Measure	DB PP3M n=215 Participants Participants received 4 doses of PP3M (350 or 525 milligrams equivalent \[mg eq.\]) intramuscular (IM) injection for up to 12 months (1 dose every 3 month) during DB phase.	DB PP6M n=459 Participants Participants received 2 doses of PP6M (700 or 1000 mg eq.) IM injection for 12 months (1 dose every 6 months), during the DB Phase. To maintain blinding, participants received IM injections of matching placebo at the 3-month time points between their 6-month doses of PP6M drug.
Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Hematology During DB Phase Eosinophils ABL	1 Participants	1 Participants
Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Hematology During DB Phase Neutrophils ABL	1 Participants	0 Participants
Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Hematology During DB Phase Basophils ABL	0 Participants	0 Participants
Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Hematology During DB Phase Erythrocytes ABL	1 Participants	0 Participants
Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Hematology During DB Phase Erythrocytes ABH	0 Participants	0 Participants
Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Hematology During DB Phase Hematocrit ABL	0 Participants	1 Participants
Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Hematology During DB Phase Hematocrit ABH	0 Participants	0 Participants
Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Hematology During DB Phase Hemoglobin ABL	1 Participants	0 Participants
Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Hematology During DB Phase Hemoglobin ABH	0 Participants	0 Participants
Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Hematology During DB Phase Leukocytes ABL	0 Participants	0 Participants
Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Hematology During DB Phase Leukocytes ABH	2 Participants	4 Participants
Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Hematology During DB Phase Lymphocytes ABL	0 Participants	2 Participants
Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Hematology During DB Phase Lymphocytes ABH	1 Participants	1 Participants
Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Hematology During DB Phase Monocytes ABH	0 Participants	0 Participants
Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Hematology During DB Phase Neutrophils ABH	0 Participants	0 Participants
Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Hematology During DB Phase Platelets ABL	0 Participants	0 Participants
Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Hematology During DB Phase Platelets ABH	0 Participants	0 Participants

Adverse Events

Open-Label (OL) PP1M/PP3M

Serious events: 23 serious events

Other events: 127 other events

Deaths: 1 deaths

Double-blind PP3M

Serious events: 15 serious events

Other events: 52 other events

Deaths: 2 deaths

Double-blind PP6M

Serious events: 24 serious events

Other events: 125 other events

Deaths: 1 deaths

Follow-up (FU) Phase PP3M

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Follow-up Phase PP6M

Serious events: 6 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	Open-Label (OL) PP1M/PP3M n=838 participants at risk Participants previously treated with oral antipsychotics, or injectable risperidone, or a moderate or higher dose of paliperidone palmitate 1-month (PP1M) with previous initiation but without previous stabilization (where stabilization was defined as at least 3 months of injections with the last 2 doses being the same strength) received 1 to 5 intramuscular (IM) injections of PP1M 50 to 150 milligrams equivalent (mg eq.). Participants received single dose of IM injection of PP1M as 100 or 150 mg eq. or PP3M as 350 or 525 mg eq during the OL-maintenance phase.	Double-blind PP3M n=224 participants at risk Participants received 4 doses of PP3M (350 or 525 mg eq. IM injection for up to 12 months (1 dose every 3 month) during DB phase.	Double-blind PP6M n=478 participants at risk Participants received 2 doses of PP6M (700 or 1000 mg eq. IM injection for 12 months (1 dose every 6 months), during the DB Phase. To maintain blinding, participants received IM injections of matching placebo at the 3-month time points between their 6-month doses of PP6M drug.	Follow-up (FU) Phase PP3M n=42 participants at risk Participants who have received at least 1 dose of PP3M (350 or 525 mg eq.) IM injection during double-blind phase but then have relapsed or have met other relevant conditions for withdrawal or discontinuation can participate in the follow-up phase PP3M (350 or 525 mg eq.) IM injection for up to 12 months for evaluating efficacy and safety.	Follow-up Phase PP6M n=109 participants at risk Participants received PP6M (700 or 1000 mg eq.) IM injection for up to 12 months for evaluating efficacy and safety.
Cardiac disorders Atrial Fibrillation	0.12% 1/838 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/224 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/478 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/42 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/109 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.
Gastrointestinal disorders Intestinal Obstruction	0.00% 0/838 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/224 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.21% 1/478 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/42 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/109 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.
General disorders Death	0.00% 0/838 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/224 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.21% 1/478 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/42 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/109 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.
General disorders Sudden Death	0.00% 0/838 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.45% 1/224 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/478 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/42 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/109 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.
Hepatobiliary disorders Cholelithiasis	0.00% 0/838 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.45% 1/224 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/478 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/42 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/109 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.
Infections and infestations Furuncle	0.12% 1/838 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/224 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/478 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/42 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/109 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.
Infections and infestations Pneumonia	0.12% 1/838 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/224 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/478 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/42 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/109 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.
Injury, poisoning and procedural complications Femur Fracture	0.00% 0/838 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.45% 1/224 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/478 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/42 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/109 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.
Injury, poisoning and procedural complications Limb Injury	0.00% 0/838 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.45% 1/224 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/478 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/42 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/109 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.
Injury, poisoning and procedural complications Radius Fracture	0.00% 0/838 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/224 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.21% 1/478 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/42 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/109 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.
Musculoskeletal and connective tissue disorders Rotator Cuff Syndrome	0.12% 1/838 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/224 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/478 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/42 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/109 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain Neoplasm	0.00% 0/838 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/224 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/478 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/42 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.92% 1/109 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic Lymphocytic Leukaemia	0.00% 0/838 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.45% 1/224 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/478 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/42 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/109 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Nasal Sinus Cancer	0.00% 0/838 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/224 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/478 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/42 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.92% 1/109 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm Malignant	0.00% 0/838 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/224 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.21% 1/478 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/42 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/109 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.
Nervous system disorders Seizure	0.00% 0/838 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/224 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.21% 1/478 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/42 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/109 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.
Pregnancy, puerperium and perinatal conditions Abortion Spontaneous	0.00% 0/838 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/224 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.21% 1/478 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/42 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/109 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.
Psychiatric disorders Acute Psychosis	0.12% 1/838 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/224 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/478 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/42 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/109 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.
Psychiatric disorders Adjustment Disorder with Mixed Anxiety and Depressed Mood	0.00% 0/838 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/224 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.21% 1/478 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/42 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/109 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.
Psychiatric disorders Adjustment Disorder with Mixed Disturbance of Emotion and Conduct	0.00% 0/838 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.45% 1/224 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/478 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/42 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/109 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.
Psychiatric disorders Alcohol Withdrawal Syndrome	0.12% 1/838 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/224 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/478 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/42 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/109 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.
Psychiatric disorders Behavioural Addiction	0.12% 1/838 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/224 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/478 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/42 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/109 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.
Psychiatric disorders Completed Suicide	0.12% 1/838 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/224 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/478 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/42 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/109 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.
Psychiatric disorders Depression	0.00% 0/838 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/224 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.21% 1/478 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/42 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/109 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.
Psychiatric disorders Hallucination, Auditory	0.00% 0/838 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.45% 1/224 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/478 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/42 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/109 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.
Psychiatric disorders Mental Disorder	0.00% 0/838 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/224 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/478 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/42 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.92% 1/109 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.
Psychiatric disorders Mixed Anxiety and Depressive Disorder	0.00% 0/838 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/224 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.21% 1/478 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/42 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/109 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.
Psychiatric disorders Panic Disorder	0.00% 0/838 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/224 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.21% 1/478 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/42 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/109 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.
Psychiatric disorders Psychotic Disorder	0.36% 3/838 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.89% 2/224 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.21% 1/478 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/42 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/109 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.
Psychiatric disorders Psychotic Symptom	0.00% 0/838 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/224 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.21% 1/478 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/42 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/109 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.
Psychiatric disorders Schizophrenia	0.72% 6/838 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.45% 1/224 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	1.7% 8/478 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/42 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	1.8% 2/109 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.
Psychiatric disorders Suicidal Ideation	0.36% 3/838 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.89% 2/224 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.21% 1/478 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	2.4% 1/42 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/109 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.
Psychiatric disorders Suicide Attempt	0.24% 2/838 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/224 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.42% 2/478 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/42 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.92% 1/109 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.
Renal and urinary disorders Pelvi-Ureteric Obstruction	0.00% 0/838 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/224 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.21% 1/478 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/42 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/109 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.
Reproductive system and breast disorders Priapism	0.00% 0/838 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/224 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.21% 1/478 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/42 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/109 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.
Respiratory, thoracic and mediastinal disorders Acute Respiratory Failure	0.00% 0/838 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.45% 1/224 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/478 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/42 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/109 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.
Respiratory, thoracic and mediastinal disorders Chronic Obstructive Pulmonary Disease	0.24% 2/838 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.45% 1/224 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/478 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/42 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/109 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.12% 1/838 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/224 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.21% 1/478 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/42 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/109 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.00% 0/838 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.45% 1/224 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/478 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/42 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/109 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.
Surgical and medical procedures Mammoplasty	0.00% 0/838 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.45% 1/224 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/478 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/42 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/109 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.
Vascular disorders Deep Vein Thrombosis	0.00% 0/838 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/224 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.21% 1/478 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/42 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/109 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.
Vascular disorders Peripheral Artery Occlusion	0.00% 0/838 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.45% 1/224 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/478 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/42 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/109 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.

Other adverse events

Measure	Open-Label (OL) PP1M/PP3M n=838 participants at risk Participants previously treated with oral antipsychotics, or injectable risperidone, or a moderate or higher dose of paliperidone palmitate 1-month (PP1M) with previous initiation but without previous stabilization (where stabilization was defined as at least 3 months of injections with the last 2 doses being the same strength) received 1 to 5 intramuscular (IM) injections of PP1M 50 to 150 milligrams equivalent (mg eq.). Participants received single dose of IM injection of PP1M as 100 or 150 mg eq. or PP3M as 350 or 525 mg eq during the OL-maintenance phase.	Double-blind PP3M n=224 participants at risk Participants received 4 doses of PP3M (350 or 525 mg eq. IM injection for up to 12 months (1 dose every 3 month) during DB phase.	Double-blind PP6M n=478 participants at risk Participants received 2 doses of PP6M (700 or 1000 mg eq. IM injection for 12 months (1 dose every 6 months), during the DB Phase. To maintain blinding, participants received IM injections of matching placebo at the 3-month time points between their 6-month doses of PP6M drug.	Follow-up (FU) Phase PP3M n=42 participants at risk Participants who have received at least 1 dose of PP3M (350 or 525 mg eq.) IM injection during double-blind phase but then have relapsed or have met other relevant conditions for withdrawal or discontinuation can participate in the follow-up phase PP3M (350 or 525 mg eq.) IM injection for up to 12 months for evaluating efficacy and safety.	Follow-up Phase PP6M n=109 participants at risk Participants received PP6M (700 or 1000 mg eq.) IM injection for up to 12 months for evaluating efficacy and safety.
General disorders Injection Site Pain	8.6% 72/838 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	4.0% 9/224 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	7.7% 37/478 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/42 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/109 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.
Infections and infestations Nasopharyngitis	2.6% 22/838 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	5.8% 13/224 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	4.6% 22/478 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	2.4% 1/42 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	3.7% 4/109 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.
Infections and infestations Upper Respiratory Tract Infection	2.3% 19/838 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	4.0% 9/224 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	5.0% 24/478 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/42 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.92% 1/109 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.
Investigations Weight Increased	0.95% 8/838 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	7.6% 17/224 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	8.4% 40/478 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/42 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/109 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.
Nervous system disorders Headache	1.9% 16/838 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	5.4% 12/224 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	6.7% 32/478 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/42 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.	0.00% 0/109 • Up to 2.5 Years Open-label (OL) safety set included all participants who received at least 1 dose of OL study drug (excluding the first study participants if re-screened), both transition and maintenance phases. Double-blind (DB) safety set included all participants who were randomly assigned to treatment group either PP6M or PP3M during DB Phase and received at least 1 dose of DB study drug. Participants from DB safety set continued in follow-up phase.

Additional Information

Compound Development Team Leader

Janssen Research & Development, LLC

Phone: 844-434-4210

Email: ClinicalTrialDisclosure@its.jnj.com

Results disclosure agreements

• Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the Sponsor for review at least 60 days before submission for publication or presentation. Expedited reviews will be arranged for abstracts, poster presentations, or other materials. If requested by the Sponsor in writing, the investigator will withhold such publication for up to an additional 60 days to allow for filing of a patent application.
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Restriction type: OTHER