Trial Outcomes & Findings for Long-acting Injectable Risperidone in Patients With Schizophrenia After an Acute Episode (NCT NCT00216671)

Last Updated: 2013-07-19

Results Overview

The PANSS is a specific scale for the measurement of the symptoms of schizophrenia. Symptoms of schizophrenia will be assessed using the 30-item PANSS scale. Each item of the scale is to be scored on a scale of 1 (absent) to 7 (extreme).The total score can range from 30 to 210.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

220 participants

Primary outcome timeframe

at baseline and Week 26 or at premature discontinuation

Results posted on

2013-07-19

Participant Flow

Participant milestones

Participant milestones
Measure	Early Initiation of Treatment 25 mg to 50 mg Risperdal Consta intramuscular (i.m.) injection every 14 days starting at baseline. Treatment with oral antipsychotics (APs) or risperidone will continue 21 days after the first injection of Risperdal Consta. This treatment will then be tapered off within the next 7 days.	Late Initiation of Treatment routine practice: The oral AP treatment started during the acute episode will be maintained until week 12. Starting at week 12, 25 mg to 50 mg Risperdal Consta i.m. injection every 14 days. Treatment with previous oral APs will continue 21 days after the first injection and then be tapered off within the next 7 days.
Overall Study STARTED	110	110
Overall Study COMPLETED	75	60
Overall Study NOT COMPLETED	35	50

Reasons for withdrawal

Reasons for withdrawal
Measure	Early Initiation of Treatment 25 mg to 50 mg Risperdal Consta intramuscular (i.m.) injection every 14 days starting at baseline. Treatment with oral antipsychotics (APs) or risperidone will continue 21 days after the first injection of Risperdal Consta. This treatment will then be tapered off within the next 7 days.	Late Initiation of Treatment routine practice: The oral AP treatment started during the acute episode will be maintained until week 12. Starting at week 12, 25 mg to 50 mg Risperdal Consta i.m. injection every 14 days. Treatment with previous oral APs will continue 21 days after the first injection and then be tapered off within the next 7 days.
Overall Study Adverse Event	4	9
Overall Study Pregnancy	0	1
Overall Study Withdrawal by Subject	4	2
Overall Study Refused Injections	3	13
Overall Study No Need to Continue Medication	1	1
Overall Study Insufficient Response	9	4
Overall Study Lost to Follow-up	3	5
Overall Study Non compliant	2	2
Overall Study Ineligible	0	2
Overall Study Physician Decision	1	1
Overall Study Protocol Violation	3	5
Overall Study Relapse	1	0
Overall Study Investigator Illness	0	1
Overall Study Patient Moved	0	1
Overall Study Ineligible, no efficacy data	2	2
Overall Study Insufficient Response Adverse Event	2	1

Baseline Characteristics

Long-acting Injectable Risperidone in Patients With Schizophrenia After an Acute Episode

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Early Initiation of Treatment n=108 Participants 25 mg to 50 mg Risperdal Consta intramuscular (i.m.) injection every 14 days starting at baseline. Treatment with oral antipsychotics (APs) or risperidone will continue 21 days after the first injection of Risperdal Consta. This treatment will then be tapered off within the next 7 days. Two enrolled patients were excluded from the baseline analysis as these patients dropped out early and no safety or efficacy data were present.	Late Initiation of Treatment n=108 Participants routine practice: The oral AP treatment started during the acute episode will be maintained until week 12. Starting at week 12, 25 mg to 50 mg Risperdal Consta i.m. injection every 14 days. Treatment with previous oral APs will continue 21 days after the first injection and then be tapered off within the next 7 days. Two enrolled patients were excluded from the baseline analysis as these patients dropped out early and no efficacy data were present.	Total n=216 Participants Total of all reporting groups
Age Continuous	38 years STANDARD_DEVIATION 11 • n=5 Participants	38 years STANDARD_DEVIATION 11 • n=7 Participants	38 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	41 Participants n=5 Participants	43 Participants n=7 Participants	84 Participants n=5 Participants
Sex: Female, Male Male	67 Participants n=5 Participants	65 Participants n=7 Participants	132 Participants n=5 Participants

PRIMARY outcome

Timeframe: at baseline and Week 26 or at premature discontinuation

Population: Per Protocol analysis: all randomized patients who had no violation on eligibility criteria or no major protocol violation. This excluded 42 patients in the early and 34 in the late initiation group. 1 patient in the early initiation group had no PANSS at endpoint. The endpoint is the last post-baseline value of the patient.

Outcome measures

Outcome measures
Measure	Early Initiation of Treatment n=65 Participants 25 mg to 50 mg Risperdal Consta intramuscular (i.m.) injection every 14 days starting at baseline. Treatment with oral antipsychotics (APs) or risperidone will continue 21 days after the first injection of Risperdal Consta. This treatment will then be tapered off within the next 7 days. Two enrolled patients were excluded from the baseline analysis as these patients dropped out early and no safety or efficacy data were present.	Late Initiation of Treatment n=74 Participants routine practice: The oral AP treatment started during the acute episode will be maintained until week 12. Starting at week 12, 25 mg to 50 mg Risperdal Consta i.m. injection every 14 days. Treatment with previous oral APs will continue 21 days after the first injection and then be tapered off within the next 7 days. Two enrolled patients were excluded from the baseline analysis as these patients dropped out early and no efficacy data were present.
Change in Positive And Negative Syndrome Scale (PANSS) Total Score From Baseline to Endpoint	-38.37 scores on a scale Standard Deviation 23.1	-37.24 scores on a scale Standard Deviation 25.02

SECONDARY outcome

Timeframe: at baseline and Week 6.

Population: Per protocol population. This excluded 42 patients in the early start group and 34 patients in the late start group. An additional 3 and 5 patients in the respective groups had missing PANSS data at week 6.

Outcome measures

Outcome measures
Measure	Early Initiation of Treatment n=63 Participants 25 mg to 50 mg Risperdal Consta intramuscular (i.m.) injection every 14 days starting at baseline. Treatment with oral antipsychotics (APs) or risperidone will continue 21 days after the first injection of Risperdal Consta. This treatment will then be tapered off within the next 7 days. Two enrolled patients were excluded from the baseline analysis as these patients dropped out early and no safety or efficacy data were present.	Late Initiation of Treatment n=69 Participants routine practice: The oral AP treatment started during the acute episode will be maintained until week 12. Starting at week 12, 25 mg to 50 mg Risperdal Consta i.m. injection every 14 days. Treatment with previous oral APs will continue 21 days after the first injection and then be tapered off within the next 7 days. Two enrolled patients were excluded from the baseline analysis as these patients dropped out early and no efficacy data were present.
Change From Baseline in PANSS Total Score at Week 6	-27.48 scores on a scale Standard Deviation 17.97	-27.96 scores on a scale Standard Deviation 20.10

SECONDARY outcome

Timeframe: at baseline and Week 12.

Population: Per protocol population. This excluded 42 patients in the early start group and 34 patients in the late start group. An additional 9 and 23 patients in the respective groups had missing PANSS data.

Outcome measures

Outcome measures
Measure	Early Initiation of Treatment n=57 Participants 25 mg to 50 mg Risperdal Consta intramuscular (i.m.) injection every 14 days starting at baseline. Treatment with oral antipsychotics (APs) or risperidone will continue 21 days after the first injection of Risperdal Consta. This treatment will then be tapered off within the next 7 days. Two enrolled patients were excluded from the baseline analysis as these patients dropped out early and no safety or efficacy data were present.	Late Initiation of Treatment n=51 Participants routine practice: The oral AP treatment started during the acute episode will be maintained until week 12. Starting at week 12, 25 mg to 50 mg Risperdal Consta i.m. injection every 14 days. Treatment with previous oral APs will continue 21 days after the first injection and then be tapered off within the next 7 days. Two enrolled patients were excluded from the baseline analysis as these patients dropped out early and no efficacy data were present.
Change From Baseline in PANSS Total Score at Week 12	-35.84 scores on a scale Standard Deviation 22.83	-34.49 scores on a scale Standard Deviation 19.12

SECONDARY outcome

Timeframe: at baseline and endpoint (week 26 or at premature discontinuation).

Population: Per protocol population. This excluded 42 patients in the early start group and 34 patients in the late start group.One additional patient in the Early Initiation group has missing CGI-S data.

The CGI-S rating scale is used to rate the severity of a subject's psychotic condition on a 7-point scale ranging from 1 (not ill) to 7 (extremely severe). This scale permits a global evaluation of the subject's condition at a given time.

Outcome measures

Outcome measures
Measure	Early Initiation of Treatment n=65 Participants 25 mg to 50 mg Risperdal Consta intramuscular (i.m.) injection every 14 days starting at baseline. Treatment with oral antipsychotics (APs) or risperidone will continue 21 days after the first injection of Risperdal Consta. This treatment will then be tapered off within the next 7 days. Two enrolled patients were excluded from the baseline analysis as these patients dropped out early and no safety or efficacy data were present.	Late Initiation of Treatment n=74 Participants routine practice: The oral AP treatment started during the acute episode will be maintained until week 12. Starting at week 12, 25 mg to 50 mg Risperdal Consta i.m. injection every 14 days. Treatment with previous oral APs will continue 21 days after the first injection and then be tapered off within the next 7 days. Two enrolled patients were excluded from the baseline analysis as these patients dropped out early and no efficacy data were present.
Change From Baseline to Endpoint in Clinical Global Impression - Severity (CGI-S)	-1.91 scores on a scale Standard Deviation 1.35	-2.03 scores on a scale Standard Deviation 1.27

SECONDARY outcome

Timeframe: at baseline and endpoint (week 26 or at premature discontinuation).

Population: Per protocol population. This excluded 42 patients in the early start group and 34 patients in the late start group.One additional patient in the Early Initation group has missing GAF data.

Overall psychological, social, and occupational functioning is rated on a scale of mental health-illness from 1 being the worst functioning to 100 being the best. Impairment in functioning due to physical (or environmental) limitations must not be included in the rating.

Outcome measures

Outcome measures
Measure	Early Initiation of Treatment n=65 Participants 25 mg to 50 mg Risperdal Consta intramuscular (i.m.) injection every 14 days starting at baseline. Treatment with oral antipsychotics (APs) or risperidone will continue 21 days after the first injection of Risperdal Consta. This treatment will then be tapered off within the next 7 days. Two enrolled patients were excluded from the baseline analysis as these patients dropped out early and no safety or efficacy data were present.	Late Initiation of Treatment n=74 Participants routine practice: The oral AP treatment started during the acute episode will be maintained until week 12. Starting at week 12, 25 mg to 50 mg Risperdal Consta i.m. injection every 14 days. Treatment with previous oral APs will continue 21 days after the first injection and then be tapered off within the next 7 days. Two enrolled patients were excluded from the baseline analysis as these patients dropped out early and no efficacy data were present.
Change From Baseline to Endpoint in Global Assessment of Functioning (GAF)	19.65 scores on a scale Standard Deviation 14.20	18.72 scores on a scale Standard Deviation 16.76

SECONDARY outcome

Timeframe: at baseline, Weeks 6, 12, and endpoint (week 26 or at premature discontinuation).

Population: Per protocol population. This excluded 42 patients in the early start group and 34 patients in the late start group.An additional 9 and 11 patients in the respective groups had missing SF-12 data.

Short Form Health Survey: A generic dual-ie, mental and physical health-scale measure of quality of life. This is a 12-item subset of the SF-36 survey that measures the same 8 domains of health. As a brief, reliable measure of overall health status, the SF-12 is the instrument of choice in large population health surveys and has been used extensively as a screening tool. SF-12 will be filled in by the patient. The scores range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.

Outcome measures

Outcome measures
Measure	Early Initiation of Treatment n=57 Participants 25 mg to 50 mg Risperdal Consta intramuscular (i.m.) injection every 14 days starting at baseline. Treatment with oral antipsychotics (APs) or risperidone will continue 21 days after the first injection of Risperdal Consta. This treatment will then be tapered off within the next 7 days. Two enrolled patients were excluded from the baseline analysis as these patients dropped out early and no safety or efficacy data were present.	Late Initiation of Treatment n=63 Participants routine practice: The oral AP treatment started during the acute episode will be maintained until week 12. Starting at week 12, 25 mg to 50 mg Risperdal Consta i.m. injection every 14 days. Treatment with previous oral APs will continue 21 days after the first injection and then be tapered off within the next 7 days. Two enrolled patients were excluded from the baseline analysis as these patients dropped out early and no efficacy data were present.
Change From Baseline to Endpoint in Quality of Life Questionnaire SF-12 Mental Component Summary (MCS)	3.25 scores on a scale Standard Deviation 9.19	2.96 scores on a scale Standard Deviation 10.76
Change From Baseline to Endpoint in Quality of Life Questionnaire SF-12 Physical Component Summary (PCS)	2.76 scores on a scale Standard Deviation 10.73	1.75 scores on a scale Standard Deviation 7.93

Adverse Events

Early Initiation of Treatment

Serious events: 18 serious events

Other events: 58 other events

Deaths: 0 deaths

Late Initiation of Treatment

Serious events: 22 serious events

Other events: 66 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

EMEA Medical Affairs Director Psychiatry

Janssen Cilag Spain

Phone: +34 91 7228043

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60

Measure	Early Initiation of Treatment n=110 participants at risk 25 mg to 50 mg Risperdal Consta intramuscular (i.m.) injection every 14 days starting at baseline. Treatment with oral antipsychotics (APs) or risperidone will continue 21 days after the first injection of Risperdal Consta. This treatment will then be tapered off within the next 7 days.	Late Initiation of Treatment n=110 participants at risk routine practice: The oral AP treatment started during the acute episode will be maintained until week 12. Starting at week 12, 25 mg to 50 mg Risperdal Consta i.m. injection every 14 days. Treatment with previous oral APs will continue 21 days after the first injection and then be tapered off within the next 7 days.
Gastrointestinal disorders Pancreatitis	0.00% 0/110 • All Adverse Events (AEs) occurring between the first study-related procedure, i.e. screening visit, and week 26 or early termination were reported. AEs described hereafter are treatment-emergent AEs, defined as AEs that were new in onset or aggravated in severity following treatment start.	0.91% 1/110 • All Adverse Events (AEs) occurring between the first study-related procedure, i.e. screening visit, and week 26 or early termination were reported. AEs described hereafter are treatment-emergent AEs, defined as AEs that were new in onset or aggravated in severity following treatment start.
Infections and infestations Lower Respiratory Tract Infection	0.00% 0/110 • All Adverse Events (AEs) occurring between the first study-related procedure, i.e. screening visit, and week 26 or early termination were reported. AEs described hereafter are treatment-emergent AEs, defined as AEs that were new in onset or aggravated in severity following treatment start.	0.91% 1/110 • All Adverse Events (AEs) occurring between the first study-related procedure, i.e. screening visit, and week 26 or early termination were reported. AEs described hereafter are treatment-emergent AEs, defined as AEs that were new in onset or aggravated in severity following treatment start.
Injury, poisoning and procedural complications Drug Toxicity	0.00% 0/110 • All Adverse Events (AEs) occurring between the first study-related procedure, i.e. screening visit, and week 26 or early termination were reported. AEs described hereafter are treatment-emergent AEs, defined as AEs that were new in onset or aggravated in severity following treatment start.	0.91% 1/110 • All Adverse Events (AEs) occurring between the first study-related procedure, i.e. screening visit, and week 26 or early termination were reported. AEs described hereafter are treatment-emergent AEs, defined as AEs that were new in onset or aggravated in severity following treatment start.
Injury, poisoning and procedural complications Overdose	1.8% 2/110 • All Adverse Events (AEs) occurring between the first study-related procedure, i.e. screening visit, and week 26 or early termination were reported. AEs described hereafter are treatment-emergent AEs, defined as AEs that were new in onset or aggravated in severity following treatment start.	1.8% 2/110 • All Adverse Events (AEs) occurring between the first study-related procedure, i.e. screening visit, and week 26 or early termination were reported. AEs described hereafter are treatment-emergent AEs, defined as AEs that were new in onset or aggravated in severity following treatment start.
Nervous system disorders Dizziness	0.00% 0/110 • All Adverse Events (AEs) occurring between the first study-related procedure, i.e. screening visit, and week 26 or early termination were reported. AEs described hereafter are treatment-emergent AEs, defined as AEs that were new in onset or aggravated in severity following treatment start.	0.91% 1/110 • All Adverse Events (AEs) occurring between the first study-related procedure, i.e. screening visit, and week 26 or early termination were reported. AEs described hereafter are treatment-emergent AEs, defined as AEs that were new in onset or aggravated in severity following treatment start.
Nervous system disorders Extrapyramidal Disorder	2.7% 3/110 • All Adverse Events (AEs) occurring between the first study-related procedure, i.e. screening visit, and week 26 or early termination were reported. AEs described hereafter are treatment-emergent AEs, defined as AEs that were new in onset or aggravated in severity following treatment start.	0.00% 0/110 • All Adverse Events (AEs) occurring between the first study-related procedure, i.e. screening visit, and week 26 or early termination were reported. AEs described hereafter are treatment-emergent AEs, defined as AEs that were new in onset or aggravated in severity following treatment start.
Nervous system disorders Mental Impairment	0.00% 0/110 • All Adverse Events (AEs) occurring between the first study-related procedure, i.e. screening visit, and week 26 or early termination were reported. AEs described hereafter are treatment-emergent AEs, defined as AEs that were new in onset or aggravated in severity following treatment start.	0.91% 1/110 • All Adverse Events (AEs) occurring between the first study-related procedure, i.e. screening visit, and week 26 or early termination were reported. AEs described hereafter are treatment-emergent AEs, defined as AEs that were new in onset or aggravated in severity following treatment start.
Nervous system disorders Neuroleptic Malignant Syndrome	0.00% 0/110 • All Adverse Events (AEs) occurring between the first study-related procedure, i.e. screening visit, and week 26 or early termination were reported. AEs described hereafter are treatment-emergent AEs, defined as AEs that were new in onset or aggravated in severity following treatment start.	0.91% 1/110 • All Adverse Events (AEs) occurring between the first study-related procedure, i.e. screening visit, and week 26 or early termination were reported. AEs described hereafter are treatment-emergent AEs, defined as AEs that were new in onset or aggravated in severity following treatment start.
Nervous system disorders Somnolence	0.00% 0/110 • All Adverse Events (AEs) occurring between the first study-related procedure, i.e. screening visit, and week 26 or early termination were reported. AEs described hereafter are treatment-emergent AEs, defined as AEs that were new in onset or aggravated in severity following treatment start.	0.91% 1/110 • All Adverse Events (AEs) occurring between the first study-related procedure, i.e. screening visit, and week 26 or early termination were reported. AEs described hereafter are treatment-emergent AEs, defined as AEs that were new in onset or aggravated in severity following treatment start.
Psychiatric disorders Acute Psychosis	0.91% 1/110 • All Adverse Events (AEs) occurring between the first study-related procedure, i.e. screening visit, and week 26 or early termination were reported. AEs described hereafter are treatment-emergent AEs, defined as AEs that were new in onset or aggravated in severity following treatment start.	0.00% 0/110 • All Adverse Events (AEs) occurring between the first study-related procedure, i.e. screening visit, and week 26 or early termination were reported. AEs described hereafter are treatment-emergent AEs, defined as AEs that were new in onset or aggravated in severity following treatment start.
Psychiatric disorders Aggression	0.91% 1/110 • All Adverse Events (AEs) occurring between the first study-related procedure, i.e. screening visit, and week 26 or early termination were reported. AEs described hereafter are treatment-emergent AEs, defined as AEs that were new in onset or aggravated in severity following treatment start.	0.00% 0/110 • All Adverse Events (AEs) occurring between the first study-related procedure, i.e. screening visit, and week 26 or early termination were reported. AEs described hereafter are treatment-emergent AEs, defined as AEs that were new in onset or aggravated in severity following treatment start.
Psychiatric disorders Anxiety	3.6% 4/110 • All Adverse Events (AEs) occurring between the first study-related procedure, i.e. screening visit, and week 26 or early termination were reported. AEs described hereafter are treatment-emergent AEs, defined as AEs that were new in onset or aggravated in severity following treatment start.	3.6% 4/110 • All Adverse Events (AEs) occurring between the first study-related procedure, i.e. screening visit, and week 26 or early termination were reported. AEs described hereafter are treatment-emergent AEs, defined as AEs that were new in onset or aggravated in severity following treatment start.
Psychiatric disorders Delusion	0.91% 1/110 • All Adverse Events (AEs) occurring between the first study-related procedure, i.e. screening visit, and week 26 or early termination were reported. AEs described hereafter are treatment-emergent AEs, defined as AEs that were new in onset or aggravated in severity following treatment start.	0.91% 1/110 • All Adverse Events (AEs) occurring between the first study-related procedure, i.e. screening visit, and week 26 or early termination were reported. AEs described hereafter are treatment-emergent AEs, defined as AEs that were new in onset or aggravated in severity following treatment start.
Psychiatric disorders Depressed Mood	0.00% 0/110 • All Adverse Events (AEs) occurring between the first study-related procedure, i.e. screening visit, and week 26 or early termination were reported. AEs described hereafter are treatment-emergent AEs, defined as AEs that were new in onset or aggravated in severity following treatment start.	1.8% 2/110 • All Adverse Events (AEs) occurring between the first study-related procedure, i.e. screening visit, and week 26 or early termination were reported. AEs described hereafter are treatment-emergent AEs, defined as AEs that were new in onset or aggravated in severity following treatment start.
Psychiatric disorders Depression	0.00% 0/110 • All Adverse Events (AEs) occurring between the first study-related procedure, i.e. screening visit, and week 26 or early termination were reported. AEs described hereafter are treatment-emergent AEs, defined as AEs that were new in onset or aggravated in severity following treatment start.	0.91% 1/110 • All Adverse Events (AEs) occurring between the first study-related procedure, i.e. screening visit, and week 26 or early termination were reported. AEs described hereafter are treatment-emergent AEs, defined as AEs that were new in onset or aggravated in severity following treatment start.
Psychiatric disorders Hallucination	1.8% 2/110 • All Adverse Events (AEs) occurring between the first study-related procedure, i.e. screening visit, and week 26 or early termination were reported. AEs described hereafter are treatment-emergent AEs, defined as AEs that were new in onset or aggravated in severity following treatment start.	0.00% 0/110 • All Adverse Events (AEs) occurring between the first study-related procedure, i.e. screening visit, and week 26 or early termination were reported. AEs described hereafter are treatment-emergent AEs, defined as AEs that were new in onset or aggravated in severity following treatment start.
Psychiatric disorders Insomnia	0.00% 0/110 • All Adverse Events (AEs) occurring between the first study-related procedure, i.e. screening visit, and week 26 or early termination were reported. AEs described hereafter are treatment-emergent AEs, defined as AEs that were new in onset or aggravated in severity following treatment start.	1.8% 2/110 • All Adverse Events (AEs) occurring between the first study-related procedure, i.e. screening visit, and week 26 or early termination were reported. AEs described hereafter are treatment-emergent AEs, defined as AEs that were new in onset or aggravated in severity following treatment start.
Psychiatric disorders Psychiatric Symptom	0.00% 0/110 • All Adverse Events (AEs) occurring between the first study-related procedure, i.e. screening visit, and week 26 or early termination were reported. AEs described hereafter are treatment-emergent AEs, defined as AEs that were new in onset or aggravated in severity following treatment start.	0.91% 1/110 • All Adverse Events (AEs) occurring between the first study-related procedure, i.e. screening visit, and week 26 or early termination were reported. AEs described hereafter are treatment-emergent AEs, defined as AEs that were new in onset or aggravated in severity following treatment start.
Psychiatric disorders Psychotic Disorder	1.8% 2/110 • All Adverse Events (AEs) occurring between the first study-related procedure, i.e. screening visit, and week 26 or early termination were reported. AEs described hereafter are treatment-emergent AEs, defined as AEs that were new in onset or aggravated in severity following treatment start.	0.91% 1/110 • All Adverse Events (AEs) occurring between the first study-related procedure, i.e. screening visit, and week 26 or early termination were reported. AEs described hereafter are treatment-emergent AEs, defined as AEs that were new in onset or aggravated in severity following treatment start.
Psychiatric disorders Schizophrenia	2.7% 3/110 • All Adverse Events (AEs) occurring between the first study-related procedure, i.e. screening visit, and week 26 or early termination were reported. AEs described hereafter are treatment-emergent AEs, defined as AEs that were new in onset or aggravated in severity following treatment start.	4.5% 5/110 • All Adverse Events (AEs) occurring between the first study-related procedure, i.e. screening visit, and week 26 or early termination were reported. AEs described hereafter are treatment-emergent AEs, defined as AEs that were new in onset or aggravated in severity following treatment start.
Psychiatric disorders Schizophrenia, Paranoid Type	0.91% 1/110 • All Adverse Events (AEs) occurring between the first study-related procedure, i.e. screening visit, and week 26 or early termination were reported. AEs described hereafter are treatment-emergent AEs, defined as AEs that were new in onset or aggravated in severity following treatment start.	2.7% 3/110 • All Adverse Events (AEs) occurring between the first study-related procedure, i.e. screening visit, and week 26 or early termination were reported. AEs described hereafter are treatment-emergent AEs, defined as AEs that were new in onset or aggravated in severity following treatment start.
Psychiatric disorders Suicidal Ideation	0.00% 0/110 • All Adverse Events (AEs) occurring between the first study-related procedure, i.e. screening visit, and week 26 or early termination were reported. AEs described hereafter are treatment-emergent AEs, defined as AEs that were new in onset or aggravated in severity following treatment start.	2.7% 3/110 • All Adverse Events (AEs) occurring between the first study-related procedure, i.e. screening visit, and week 26 or early termination were reported. AEs described hereafter are treatment-emergent AEs, defined as AEs that were new in onset or aggravated in severity following treatment start.
Renal and urinary disorders Urinary Incontinence	0.00% 0/110 • All Adverse Events (AEs) occurring between the first study-related procedure, i.e. screening visit, and week 26 or early termination were reported. AEs described hereafter are treatment-emergent AEs, defined as AEs that were new in onset or aggravated in severity following treatment start.	0.91% 1/110 • All Adverse Events (AEs) occurring between the first study-related procedure, i.e. screening visit, and week 26 or early termination were reported. AEs described hereafter are treatment-emergent AEs, defined as AEs that were new in onset or aggravated in severity following treatment start.
Reproductive system and breast disorders Epididymitis	0.91% 1/110 • All Adverse Events (AEs) occurring between the first study-related procedure, i.e. screening visit, and week 26 or early termination were reported. AEs described hereafter are treatment-emergent AEs, defined as AEs that were new in onset or aggravated in severity following treatment start.	0.00% 0/110 • All Adverse Events (AEs) occurring between the first study-related procedure, i.e. screening visit, and week 26 or early termination were reported. AEs described hereafter are treatment-emergent AEs, defined as AEs that were new in onset or aggravated in severity following treatment start.
Skin and subcutaneous tissue disorders Erysipelas	0.91% 1/110 • All Adverse Events (AEs) occurring between the first study-related procedure, i.e. screening visit, and week 26 or early termination were reported. AEs described hereafter are treatment-emergent AEs, defined as AEs that were new in onset or aggravated in severity following treatment start.	0.00% 0/110 • All Adverse Events (AEs) occurring between the first study-related procedure, i.e. screening visit, and week 26 or early termination were reported. AEs described hereafter are treatment-emergent AEs, defined as AEs that were new in onset or aggravated in severity following treatment start.
Surgical and medical procedures Self-medication	0.00% 0/110 • All Adverse Events (AEs) occurring between the first study-related procedure, i.e. screening visit, and week 26 or early termination were reported. AEs described hereafter are treatment-emergent AEs, defined as AEs that were new in onset or aggravated in severity following treatment start.	0.91% 1/110 • All Adverse Events (AEs) occurring between the first study-related procedure, i.e. screening visit, and week 26 or early termination were reported. AEs described hereafter are treatment-emergent AEs, defined as AEs that were new in onset or aggravated in severity following treatment start.