(a) Stable remission was achieved if, during the last 4 weeks of the 16-week OL stabilization phase the subject had not met DSM-IV-TR criteria for active mood disorder; the subject had no crisis interventions; the subject's Young Mania Rating Scale (YMRS) and Montgomery-Asberg Depression Rating Scale (MADRS) total scores both remained less than or equal to 10 and the Clinical Global Impression -- bipolar severity (CGI-BP-S) score remained less than or equal to 3 and the subject's medications and doses of other psychotropic medications remained unchanged.
(b) RMB = a fully independent, blinded, international board of 3 psychiatrists considered experts in the treatment of bipolar disorder. They reviewed all clinical data and determined whether the patient met relapse criteria.
(1) Aphs L, Kujawa M, Macfadden W et al., Frequently relapsing bipolar disorder: evidence for an effective treatment using adjunctive risperidone long-acting injectable, presented at the 14th Biennial Winter Workshop on Schizophrenia, Montreux, Switzerland, February 2008.
(2) The Global Burden of Disease. World Health Organization, 2003. Available at http://www.who.int/mip/2003/other_documents/en/globalburdenofdisease.pdf, accessed January 18, 2008
(3) DSM-IV-TR, American Psychiatric Association, 2000.
(4) DSM-IV, American Psychiatric Association, 2000.
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