Table 3.

Criteria for the evaluation of psychiatric symptom aggravation/recurrence

Satisfaction of at least 1 of the following 4 requirements
1)	CGI-I is 5 (minimally worse) or higher, and at least 1 of A and B is satisfied
	A. Scored 5 (moderate severe) or higher in any of the following PANSS items, i.e., “disturbed concept integration (P2)”, “hallucination-based behavior (P3)”, “doubt/persecutory sense (P6)”, and “unnatural thought content (G9)” with a score on such item(s) being higher by 2 or more points from the baseline score
	B. Scored 5 (moderate severe) or higher in any of the following PANSS items, i.e., “disturbed concept integration (P2)”, “hallucination-based behavior (P3)”, “doubt/persecutory sense (P6)”, and “unnatural thought content (G9)”, with a total score on these 4 items being higher by 4 or more points from the baseline score
2)	Hospitalized based on psychiatric symptom aggravation
3)	CGI-SS Part 1 rating of 4 (severely suicidal) or 5 (attempted suicide), or CGI-SS Part 2 rating of 6 (much worse) or 7 (very much worse)
4)	Behaved violently, causing clinically serious self-injury, injury to other people, or destruction of objects