| Primary | Change From Baseline in Personal and Social Performance (PSP) Scale Score at Week 52 | The PSP assesses degree of participant's dysfunction within 4 domains of behavior, socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate degree of difficulty (1=absent to 6=very severe) in each of 4 domains. Based on the 4 domains there will be one total score. Participants with a score of 71 to 100 have a 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. | Intent-to-treat (ITT) population included all randomized participants who received at least one dose of study medication and fulfilled all inclusion and exclusion criteria. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline and Week 52 | | | | ID | Title | Description |
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| OG000 | Risperidone Long Acting Injectables | Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52. | | OG001 | Risperidone Tablets | Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52. |
| | | Title | Denominators | Categories |
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| Baseline | | | Title | Measurements |
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| - OG00050.65± 14.19
- OG00158.71± 9.82
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| | Change at Week 52 | | |
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| Change from Baseline in Personal and Social Performance (PSP) Scale Score at Week 52 | t-test, 2 sided | | 0.8595 | | Mean Difference (Final Values) | -0.61 | | | 2-Sided | 95 | -7.5 | 6.3 | | | | Yes | Non-Inferiority or Equivalence | 80% of power and 0.05 of significance level was used | |
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| Secondary | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Score at Week 52 | The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening. | ITT population included all randomized participants who received at least one dose of study medication and fulfilled all inclusion and exclusion criteria. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline and Week 52 | | | | ID | Title | Description |
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| OG000 | Risperidone Long Acting Injectables | Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52. | | OG001 | Risperidone Tablets | Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52. |
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| Secondary | Change From Baseline in Clinical Global Impression-Severity Scale (CGI-S) Score at Week 52 | The CGI rating scale is a 7-point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill participants". Higher scores indicate worsening. | ITT population included all randomized participants who received at least one dose of study medication and fulfilled all inclusion and exclusion criteria. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline and Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Risperidone Long Acting Injectables | Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52. | | OG001 | Risperidone Tablet | Risperidone tablet were administered orally as 0.5-10 mg daily up to Week 52. |
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| Secondary | Change From Baseline in Social Functioning Scale (SFS) Score at Week 52 | Social Functioning Scale (SFS) scores from 0 to 223 wherein, following categories were involved: Social Engagement (Score Range 0-15); Interpersonal Communication (Score Range 0-9); Recreational Activities (Score Range 0-45); Social Activities (Score Range 0-66; Independence Competence (Score Range 0-39); Independence Performance (Score Range 0-39); Occupational Activity (Score Range 0-10). Total score is sum of all sub scores and higher score indicates better level of social functioning. | ITT population included all randomized participants who received at least one dose of study medication & fulfilled eligibility criteria. 'N' (number of participants analyzed) signifies participants evaluable for this measure."n" signifies participants who were evaluated for this measure at specified timepoint for each arm group respectively. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline and Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Risperidone Long Acting Injectables | Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52. | | OG001 | Risperidone Tablets | Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52. |
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| Secondary | Change From Baseline in Emotional & Social Functioning Scale (SFS) Score at Week 52 | For emotional and SFS, mean scores of neuroticism-extroversion-openness (NEO) personality test, relationship style questionnaire (RSQ), state-trait anger expression inventory (STAXI), positive affect and negative affect schedule (PANAS), emotional intelligence (EI), beck depression inventory (BDI), and beck anxiety inventory (BAI) scales were calculated. Score ranges for each category as:60-300 for NEO, 30-150 for RSQ, 20-80 for STAXI, 20-100 for PANAS, 8-172 for EI, 0-63 for BDI and BAI. Higher score indicates improvement. | ITT population included all randomized participants who received at least one dose of study medication & fulfilled eligibility criteria. 'N' (number of participants analyzed) signifies participants evaluable for this measure."n" signifies participants who were evaluated for this measure at specified timepoint for each arm group respectively. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline and Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Risperidone Long Acting Injectables | Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52. | | OG001 | Risperidone Tablets | Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52. |
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| Secondary | Change From Baseline in Verbal Working Memory (VWM) Response Based on Neurocognitive Function Test (NCFT) at Week 52 | The NCFT is neuropsychological test which measures psychological functions. The VWM was measured by Korean-Wechsler Adults Intelligence Scale (K-WAIS), which consists of two subscales, the Verbal scale (6 subtests) and the Performance scale (5 subtests). The verbal tests were: information, comprehension, arithmetic, digit span, similarities, and vocabulary. Arithmetic and Digit Span test of Verbal WAIS scales was conducted. Arithmetic test (arithmetic questions were asked orally) involved calculations that measured concentration while manipulating mental mathematical problems. Digit span test (children were asked to repeat the orally given sequences of numbers either as heard or in reverse order) measured attention, concentration, and mental control. Here, mean number of correct responses in limited time period are reported for arithmetic (calculation) and Digit span. Increase in number of correct response indicates improvement. | ITT population included all randomized participants who received at least one dose of study medication & fulfilled eligibility criteria. 'N' (number of participants analyzed) signifies participants evaluable for this measure."n" signifies participants who were evaluated for this measure at specified timepoint for each arm group respectively. | Posted | | Mean | Standard Deviation | Correct responses | | Baseline and Week 52 | | | | ID | Title | Description |
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| OG000 | Risperidone Long Acting Injectables | Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52. |
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| Secondary | Change From Baseline in Trail Making Test Based on Neurocognitive Function Test (NCFT) at Week 52 | The NCFT is neuropsychological test which measures psychological functions. The Trail Making Test is composed of two Parts, A and B. Part A consists of 25 circles printed on a sheet of paper. Each circle contains a number from 1 to 25. The participant's task is to connect the circles with a pencil line as quickly as possible, beginning with the number 1 and proceeding in numerical sequence. Part B consists of 25 circles numbered from 1 to 13 and lettered from A to L. The task in Part B is to connect the circles, in sequence, alternating between numbers and letters. Here, mean number of seconds are represented required to complete each Part. | ITT population included all randomized participants who received at least one dose of study medication & fulfilled eligibility criteria. 'N' (number of participants analyzed) signifies participants evaluable for this measure."n" signifies participants who were evaluated for this measure at specified timepoint for each arm group respectively. | Posted | | Mean | Standard Deviation | Seconds | | Baseline and Week 52 | | | | ID | Title | Description |
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| OG000 | Risperidone Long Acting Injectables | Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52. | | OG001 | Risperidone Tablets | Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52. |
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| Secondary | Change From Baseline in Working Memory Based on Neurocognitive Function Test (NCFT) at Week 52 | The NCFT is neuropsychological test which measures psychological functions. Working memory was assessed using Controlled Oral Word Association Test (COWAT) which measured verbal fluency and is a sub-test of the multilingual aphasia examination. The COWAT uses the three letter set of C, F, and L to assess phonemic fluency. Individuals are given 1 minute to name as many words as possible beginning with one of the letters. The procedure is then repeated for the remaining two letters. More words indicate improvement. | ITT population included all randomized participants who received at least one dose of study medication & fulfilled eligibility criteria. 'N' (number of participants analyzed) signifies participants evaluable for this measure."n" signifies participants who were evaluated for this measure at specified timepoint for each arm group respectively. | Posted | | Mean | Standard Deviation | Words | | Baseline and Week 52 | | | | ID | Title | Description |
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| OG000 | Risperidone Long Acting Injectables | Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52. | | OG001 | Risperidone Tablets | Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52. |
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| Secondary | Change From Baseline in Continuous Performance Task (CPT) Based on Neurocognitive Function Test (NCFT) at Week 52 | The NCFT is neuropsychological test which measures psychological functions. The CPT assessed CPT (Omissions) and CPT (Commissions). Omission errors indicate the number of times the target was presented, but the participant did not respond/click the mouse. High omission rates indicate that the participant is either not paying attention (distractibility) to stimuli or has a sluggish response. Commission errors indicate the number of times the participant responded but no target was presented. A fast reaction time and high commission error rate points to difficulties with impulsivity. A slow reaction time with high commission and omission errors indicates inattention in general. | ITT population included all randomized participants who received at least one dose of study medication & fulfilled eligibility criteria. 'N' (number of participants analyzed) signifies participants evaluable for this measure."n" signifies participants who were evaluated for this measure at specified timepoint for each arm group respectively. | Posted | | Mean | Standard Deviation | Errors | | Baseline and Week 52 | | | | ID | Title | Description |
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| OG000 | Risperidone Long Acting Injectables | Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52. | | OG001 | Risperidone Tablets | |
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| Secondary | Change From Baseline in Theory of Mind (TOM) Scale Score at Week 52 | The TOM scale is used to assess the ability of participant to infer other's mental states. It includes recognition that other individuals experience thoughts, feelings, intentions, and desires. It is measured by cartoon task, score ranging from 0-30 and stork task which includes stork task set A (false belief), stork task set B (double bluff, white lie, persuasion, misunderstanding), and physical story, score ranging from 0-12, 0-26 and 0-24 respectively. Higher score indicates improvement. | ITT population included all randomized participants who received at least one dose of study medication & fulfilled eligibility criteria. 'N' (number of participants analyzed) signifies participants evaluable for this measure."n" signifies participants who were evaluated for this measure at specified timepoint for each arm group respectively. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline and Week 52 | | | | ID | Title | Description |
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| OG000 | Risperidone Long Acting Injectables | Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52. | | OG001 | Risperidone Tablets | Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52. |
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| Secondary | Change From Baseline in Psychosocial Well-being Index (PWI) Score at Week 52 | Psychosocial Well-being Index (PWI) is a questionnaire about how the participant feels and how the things had been going with them. Total score ranges from 0 to 135, where lower score indicates worsening. | ITT population included all randomized participants who received at least one dose of study medication & fulfilled eligibility criteria. 'N' (number of participants analyzed) signifies participants evaluable for this measure."n" signifies participants who were evaluated for this measure at specified timepoint for each arm group respectively. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline and Week 52 | | | | ID | Title | Description |
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| OG000 | Risperidone Long Acting Injectables | Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52. | | OG001 | Risperidone Tablets | Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52. |
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| Secondary | Change From Baseline in Global Assessment of Functioning (GAF) Test Score at Week 52 | The GAF is a 100-point tool rating overall psychological, social and occupational functioning of adults. The higher score range (91 to 100) refers to a superior functioning in a wide range of activities, and absence of symptoms. The lower score range (1 to 10) refers to persistent danger of severely hurting self or others; or persistent inability to maintain minimum personal hygiene; or serious suicidal act with clear expectation of death. | ITT population included all randomized participants who received at least one dose of study medication and fulfilled all inclusion and exclusion criteria. "n" signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline and Week 52 | | | | ID | Title | Description |
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| OG000 | Risperidone Long Acting Injectables | Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52. | | OG001 | Risperidone Tablets | Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52. |
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| Secondary | Change From Baseline in Scale to Assess Unawareness of Mental Disorder (SUMD) Score at Week 52 | The SUMD scale is a semi-structured scale that assesses participant's awareness of and insight into their illness, that is, the present level of insight. SUMD total score ranges from 0-27, with higher scores indicating poorer insight. The scale consists of nine items score ranging from 1 to 3, with higher scores indicating poorer insight. Score for each item is summed to produce the total score. | ITT population included all randomized participants who received at least one dose of study medication and fulfilled all inclusion and exclusion criteria. "n" signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline and Week 52 | | | | ID | Title | Description |
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| OG000 | Risperidone Long Acting Injectables | Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52. | | OG001 | Risperidone Tablets | Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52. |
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| Secondary | Change From Baseline in Drug Attitude Inventory-10 (DAI-10) Score at Week 52 | The DAI-10 is a 10-item questionnaire to assess 1) subjective experience of drug and 2) attitudes and beliefs toward neuroleptics which may influence compliance in schizophrenia participants. Score ranges from (-) 10 to 10. It is the binary scale assessing the participant's subjective response. A 'compliant' response is scored as +1; a dysphoric response is scored as -1. A positive sum of items indicates a positive subjective response (SR); a negative sum of scores indicates a negative SR (non-compliant). | ITT population included all randomized participants who received at least one dose of study medication & fulfilled eligibility criteria. 'N' (number of participants analyzed) signifies participants evaluable for this measure."n" signifies participants who were evaluated for this measure at specified timepoint for each arm group respectively. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline and Week 52 | | | | ID | Title | Description |
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| OG000 | Risperidone Injection | Risperidone long acting injectable (LAI) were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52. | | OG001 | Risperidone Tablet | Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52. |
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| Secondary | Change From Baseline in Members for Outpatients, Members Visiting Inpatients, Affected Members and Visiting Inpatients at Week 52 | Healthcare economics questionnaire consists of 13-Questions, which measured disease burden on participant; out of which 4 questions are related to number of members for outpatients, number of members visiting inpatients, number of affected members and number of visiting inpatients. Mean-calculations were done for all questions. Higher value indicates more disease burden. Change from Baseline is the value at Week 52 minus value at Baseline. | ITT population included all randomized participants who received at least one dose of study medication & fulfilled eligibility criteria. 'N' (number of participants analyzed) signifies participants evaluable for this measure."n" signifies participants who were evaluated for this measure at specified timepoint for each arm group respectively. | Posted | | Mean | Standard Deviation | participants | | Baseline and Week 52 | | | | ID | Title | Description |
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| OG000 | Risperidone Long Acting Injectables | Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52. | | OG001 | Risperidone Tablets | Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52. |
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| Secondary | Change From Baseline in Days of Hospitalization, Number of Days Affected by Participants and Family, at Week 52 | Healthcare economics questionnaire consists of 13-Questions, which measured disease burden on participant; out of which 3 questions are related to days of hospitalization, number of days affected by participants and family per participant within reporting interval score. Mean-calculations were done for all questions. Change from Baseline is the value at Week 52 minus value at Baseline. | ITT population included all randomized participants who received at least one dose of study medication & fulfilled eligibility criteria. 'N' (number of participants analyzed) signifies participants evaluable for this measure."n" signifies participants who were evaluated for this measure at specified timepoint for each arm group respectively. | Posted | | Mean | Standard Deviation | days | | Baseline and Week 52 | | | | ID | Title | Description |
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| OG000 | Risperidone Long Acting Injectables | Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52. | | OG001 | Risperidone Tablets | Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52. |
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| Secondary | Change From Baseline in Total Outpatients and Inpatients Hours at Week 52 | Healthcare economics questionnaire consists of 13-Questions, which measured disease burden on participant; out of which 2 questions are related to total outpatients and inpatients hours. Total outpatients hours and total inpatient hours indicate the total hours spent by outpatients and inpatients respectively at Investigator site.Mean-calculations were done for all questions. Higher value indicates more disease burden. Change from Baseline is the value at Week 52 minus value at Baseline. | ITT population included all randomized participants who received at least one dose of study medication and fulfilled all inclusion and exclusion criteria. "n" signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively. | Posted | | Mean | Standard Deviation | hours | | Baseline and Week 52 | | | | ID | Title | Description |
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| OG000 | Risperidone Long Acting Injectables | Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52. | | OG001 | Risperidone Tablets | Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52. |
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| Secondary | Change From Baseline in Travelling Fee for Outpatients, Hospitalization Travelling Fee and Salary Paid a Participant Before Being Ill at Week 52 | Healthcare economics questionnaire consists of 13-Questions, which measured disease burden on participant; out of which 3 questions are related to travelling fee for outpatients, hospitalization travelling fee and salary paid a participant before being ill. Mean-calculations were done for all questions. Travelling fee, hospitalization travelling fee and salary paid were assessed for every past three months. Higher value indicates more disease burden. Change from Baseline is the value at Week 52 minus value at Baseline. | ITT population included all randomized participants who received at least one dose of study medication & fulfilled eligibility criteria. 'N' (number of participants analyzed) signifies participants evaluable for this measure."n" signifies participants who were evaluated for this measure at specified timepoint for each arm group respectively. | Posted | | Mean | Standard Deviation | Won | | Baseline and Week 52 | | | | ID | Title | Description |
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| OG000 | Risperidone Long Acting Injectables | Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52. | | OG001 | Risperidone Tablets | Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52. |
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| Secondary | Change From Baseline in Number of Outpatient Clinic Visits at Week 52 | Healthcare economics questionnaire consists of 13-Questions, which measured disease burden on participant; out of which 1 question is related to number of outpatient clinic visits. Mean-calculations were done for all questions. Higher value indicates more disease burden. Change from Baseline is the value at Week 52 minus value at Baseline. | ITT population included all randomized participants who received at least one dose of study medication & fulfilled eligibility criteria. 'N' (number of participants analyzed) signifies participants evaluable for this measure."n" signifies participants who were evaluated for this measure at specified timepoint for each arm group respectively. | Posted | | Mean | Standard Deviation | number of visits | | Baseline and Week 52 | | | | ID | Title | Description |
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| OG000 | Risperidone Long Acting Injectables | Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52. | | OG001 | Risperidone Tablets | Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52. |
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| Secondary | Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Score at Week 52 | The AIMS rates the severity of involuntary movements from 0 (none) to 4 (severe), including facial and oral movements, extremity movements, trunk movements, global and judgments, and 2 additional items concerning dental status (yes/no). A total score (ranging from 0 to 28) will be calculated as the sum of items 1 to 7. | Safety analysis population included all randomized subjects who received risperidone injection or risperidone tablets at least once. "n" signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively. | Posted | | Median | Full Range | units on a scale | | Baseline and Week 52 | | | | ID | Title | Description |
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| OG000 | Risperidone Long Acting Injectables | Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52. | | OG001 | Risperidone Tablets | Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52. |
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| Secondary | Change From Baseline in Simpson and Angus Rating Scale (SAS) Score at Week 52 | The SAS rates 10 items 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 global score is the average score (total sum of items score divided by the number of items) and ranges between 0 and 4, where the higher score denotes more severe condition of extra pyramidal symptoms. | Safety analysis population included all randomized subjects who received risperidone injection or risperidone tablets at least once. "n" signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively. | Posted | | Median | Full Range | units on a scale | | Baseline and Week 52 | | | | ID | Title | Description |
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| OG000 | Risperidone Long Acting Injectables | Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52. | | OG001 | Risperidone Tablets | Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52. |
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| Secondary | Change From Baseline in Barnes Akathisia Rating Scale (BARS) Score at Week 52 | The BARS includes an objective rating, 2 subjective ratings of symptoms of akathisia (awareness of restlessness and reported distress related to restlessness: ranging from 0 to 3), and a global clinical rating of akathisia (GCRA), ranging from 0 (absent) to 5 (severe). The global rating score, that is scored separately, is the most relevant measure of severity of akathisia. Higher scores denote worsening akathisia. | Safety analysis population included all randomized subjects who received risperidone injection or risperidone tablets at least once. "n" signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively. | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline and Week 52 | | | | ID | Title | Description |
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| OG000 | Risperidone Long Acting Injectables | Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52. | | OG001 | Risperidone Tablets | Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52. |
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