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We did not receive any written comments in response to the New Technology Town Hall meeting notice published in the Federal Register regarding the substantial clinical improvement criterion for VANFLYTA

doi:10.1016/j.jad.2011.06.005 Farokhnia M, Azarkolah A, Adinehfar F, Khodaie-Ardakani MR, Hosseini SM, Yekehtaz H, Tabrizi M, Rezaei F, Salehi B, Sadeghi SM, Moghadam M, Gharibi F, Mirshafiee O, Akhondzadeh S (2013) N -acetylcysteine as an adjunct to risperidone for treatment of negative symptoms in patients with chronic schizophrenia: a randomized, double-blind, placebo-controlled study

In addition, abrupt discontinuation of lithium increases the risk of relapse, so lithium must be withdrawn gradually if necessary

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This could make these unapproved peptides much more widely available