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Informed Consent

Informed Consent. Schizophrenia / Bipolar Studies Patient Consent Only: 98.5% Legal Representative Only: 0% Both Patient and Legal Representative 1.5% Dementia Study Patient Consent Only 49% Legal Representative Only 41% Both Patient and Legal Representative 10%. 4614.01.

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Informed Consent

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  1. Informed Consent • Schizophrenia / Bipolar Studies • Patient Consent Only: 98.5% • Legal Representative Only: 0% • Both Patient and Legal Representative 1.5% • Dementia Study • Patient Consent Only 49% • Legal Representative Only 41% • Both Patient and Legal Representative 10% 4614.01

  2. Efficacy Measures: Schizophrenia Dose Mean Change from Baseline to 2 hours (LOCF) * p<0.05 vs placebo 4058.03

  3. Vital Signs: Presence / Absence of Dose-Response RelationshipMean Change from Baseline to 2 hours - Schizophrenia Dose No linear, quadratic, or cubic relationship between the doses (2.5, 5, 7.5, and 10 mg) of Olanzapine 4408.01

  4. Agitation-Calmness Evaluation Scale: Schizophrenia Dose Scores at 2 hours after first IM injection IMOlz2.5 IMOlz5.0 IMOlz7.5 IMOlz10 IMHal7.5 IMPla 4034.03

  5. Agitation-Calmness Evaluation Scale High levels of physical activity; markedly increased levels of verbal expression; may be physically violent; cannot control signs of agitation if requested to do so; may require continuous supervision and / or physical restraint 1. Marked Agitation 2. Moderate Agitation 3. Mild Agitation 4. Normal 5. Mild Calmness 6. Moderate Calmness 7. Marked Calmness 8. Deep Sleep 9. Unarousable Normal levels of physical activity;normal levels of verbal expression; awake with eyes continuously open Sleeping lightly;aroused by mild to moderate verbal or physical stimulation; greatly reduced verbal or physical activity Sleeping deeply;cannot be aroused by vigorous verbal or physical stimulation 4169.04

  6. Dementia Diagnosis BreakdownDementia Study • Dementia Subtype (N=272) • Alzheimer's: 59.9% (n=163) • Vascular: 22.4% (n=61) • Mixed: 17.6% (n=48) 4619.01

  7. Concomitant Medications NOT Allowed: Dementia Study Guanethidine Methyldopa Reserpine Neuroleptics Benzodiazepines Anticonvulsants Antidepressants Lithium Psychostimulants Other Psychotropic Drugs Amantadine Anti-Parkinsonian Drugs Anorexics Antiemetics Cough and Cold Preparations1 1With the exception of loratadine (Claritin) 4434.02

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