ITT populationsEASTERN: n=216WESTERN: n=234

Randomized to asenapine and received 1 treatment

EASTERN: n=241WESTERN: n=244

Randomized to olanzapine and received 1 treatment

EASTERN: n=240WESTERN: n=224

EASTERN WESTERNDiscontinuations 85 (35.3%) 123 (50.4%) AEs* 36 (14.9%) 42 (17.2%) Worsening symptoms 22 (9.1%) 25 (10.2%) Other 14 (5.8%) 17 (7.0%) Lack of efficacy 7 (2.9%) 12 (4.9%) Withdrew consent 31 (12.9%) 32 (13.1%) Lost to follow-up 4 (1.7%) 12 (4.9%) Other 7 (2.9%) 25 (10.2%)

Completed 26-weeks of treatmentEASTERN: n=156 (64.7%)WESTERN: n=121 (49.6%)

ITT populationsEASTERN: n=217WESTERN: n=218

Screened subjectsEASTERN (N=576)WESTERN (N=803)

ITT populationsEASTERN: n=122WESTERN: n=83

Entered 26-week extension and received 1 treatment

EASTERN: n=134WESTERN: n=86 and 85

Entered 26-week extension and received 1 treatment

EASTERN: n=172WESTERN: n=110

Completed 52 weeks of treatment†

EASTERN: n=113 (84.3%)WESTERN: n=57 (66.3%)

ITT populationsEASTERN: n=157WESTERN: n=110

Completed 26 weeks of treatmentEASTERN: n=193 (80.4%)WESTERN: n=143 (63.8%)

Completed 52 weeks of treatment†

EASTERN: n=153 (89.0%)WESTERN: n=89 (80.9%)

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EASTERN WESTERNDiscontinuations 47 (19.6%) 81 (36.2%) AEs* 18 (7.5%) 30 (13.4%) Worsening symptoms 6 (2.5%) 16 (7.1%) Other 12 (5.0%) 14 (6.3%) Lack of efficacy 5 (2.1%) 7 (3.1%) Withdrew consent 19 (7.9%) 26 (11.6%) Lost to follow-up 1 (0.4%) 5 (2.2%) Other 4 (1.7%) 13 (5.8%)

Excluded, nonrandomizedEASTERN (n=95)

WESTERN (n=335)

EASTERN WESTERNDiscontinuations 21 (15.7%) 29 (33.7%) AEs* 10 (7.5%) 7 (8.1%) Worsening symptoms 5 (3.7%) 5 (5.8%) Other 5 (3.7%) 2 (2.3%) Lack of efficacy 0 (0.0%) 2 (2.3%) Withdrew consent 3 (2.2%) 3 (3.5%) Lost to follow-up 0 (0.0%) 1 (1.2%) Other 8 (6.0%) 16 (18.6%)

EASTERN WESTERNDiscontinuations 19 (11.0%) 21 (19.1%) AEs* 7 (4.1%) 4 (3.6%) Worsening symptoms 3 (1.7%) 1 (0.9%) Other 4 (2.3%) 3 (2.7%) Lack of efficacy 0 (0.0%) 2 (1.8%) Withdrew consent 9 (5.2%) 5 (4.5%) Lost to follow-up 0 (0.0%) 0 (0.0%) Other 3 (1.7%) 10 (9.1%)

Supplementary Figure A

Disposition of subjects. AE=adverse events; ITT=intent-to-treat populations (received 1 dose of study medication and had 1 post-baseline primary efficacy assessment). *Discontinuations due to AEs based on end-of-treatment disposition forms; compare to Table 4, showing discontinuations due to AEs based on AE reporting forms. (If the subject’s condition remained the same within the scope of the illness, it was documented as ‘Lack of efficacy’ as reason for discontinuation and not documented as an AE or AE as a reason for discontinuation. If the subject’s condition worsened outside the scope of their illness, it was documented as an AE or AE as a reason for discontinuation.) †Based on number of subjects entering the respective extension study.Countries in which these studies were conducted: EH studies (Australia, the Czech Republic, Denmark, Finland, France, Germany, Hungary, Italy, Poland, Romania, Russia, South Africa, Spain, Sweden, and the United Kingdom); WH studies (Brazil, Canada, Chile, Mexico, and the United States).