AD-5423_2

/ 2 /2.7 /CTD 8 8 II II 1 2 6 mg/ 6 mg/ HIV C 80 mmhg 3 1 3 80 mmhg 31

/ 2 /2.7 /CTD 8 8 II II 1 2 3 23 32

/ 2 /2.7 /CTD 2.7.3.3.1-28 123 2.7.3.3.1-2 8 1 2 3 2.7.3.3.1-3 2.7.3.3.1-48 2.7.3.3.1-5 40 5 7 I3 3040% II 1999 25) 1 11) 33

/ 2 /2.7 /CTD PANSS PANSS 2 70 8090 PANSS p < 0.15 2.7.3.3.1-3 LNS LNS HPD LNS RIS n % n % n % n % n % 121 117 156 144 277 70 57.9 68 58.1 88 56.4 75 52.1 158 57.0 51 42.1 49 41.9 68 43.6 69 47.9 119 43.0 < 65 121 100.0 117 100.0 133 85.3 133 92.4 254 91.7 65 0 0.0 0 0.0 23 14.7 11 7.6 23 8.3 42.4 43.0 45.0 46.0 43.9 SD 12.5 13.3 14.8 14.5 13.9 Min 17 16 20 16 17 Max 64 64 79 79 79 61.64 61.82 61.48 61.15 61.55 kg SD 13.05 14.56 12.73 12.94 12.84 Min 37.6 40.4 35.6 34.6 35.6 Max 102.0 128.0 102.0 105.0 102.0 < 1 7 5.8 9 7.7 9 5.8 9 6.3 16 5.8 1 <2 10 8.3 3 2.6 4 2.6 4 2.8 14 5.1 2 <3 8 6.6 4 3.4 6 3.8 3 2.1 14 5.1 3 <5 13 10.7 9 7.7 13 8.3 12 8.3 26 9.4 5 <10 20 16.5 18 15.4 24 15.4 28 19.4 44 15.9 10 60 49.6 73 62.4 97 62.2 80 55.6 157 56.7 3 2.5 1 0.9 3 1.9 8 5.6 6 2.2 32 26.4 37 31.6 65 41.7 65 45.1 97 35.0 ICD-10 34 28.1 43 36.8 32 20.5 34 23.6 66 23.8 4 3.3 3 2.6 9 5.8 5 3.5 13 4.7 17 14.0 7 6.0 11 7.1 13 9.0 28 10.1 0 0.0 1 0.9 0 0.0 0 0.0 0 0.0 32 26.4 25 21.4 36 23.1 27 18.8 68 24.5 1 0.8 1 0.9 2 1.3 0 0.0 3 1.1 1 0.8 0 0.0 1 0.6 0 0.0 2 0.7 34

/ 2 /2.7 /CTD LNS LNS HPD LNS RIS n % n % n % n % n % 121 117 156 144 277 32 26.4 37 31.6 65 41.7 65 45.1 97 35.0 (DSM-III-R 31 25.6 39 33.3 33 21.2 29 20.1 64 23.1 DSM-IV) 4 3.3 3 2.6 9 5.8 5 3.5 13 4.7 19 15.7 12 10.3 12 7.7 15 10.4 31 11.2 35 28.9 25 21.4 37 23.7 30 20.8 72 26.0 0 0.0 1 0.9 0 0.0 0 0.0 0 0.0 1 0.8 1 0.9 3 1.9 0 0.0 4 1.4 10 8.3 17 14.5 15 9.6 13 9.0 25 9.0 4 3.3 4 3.4 4 2.6 6 4.2 8 2.9 66 54.5 58 49.6 73 46.8 68 47.2 139 50.2 2 1.7 2 1.7 6 3.8 2 1.4 8 2.9 18 14.9 20 17.1 21 13.5 24 16.7 39 14.1 7 5.8 3 2.6 8 5.1 8 5.6 15 5.4 4 3.3 1 0.9 9 5.8 9 6.3 13 4.7 9 7.4 11 9.4 17 10.9 14 9.7 26 9.4 21 17.4 28 23.9 42 26.9 41 28.5 63 22.7 9 7.4 7 6.0 14 9.0 16 11.1 23 8.3 I 8 6.6 3 2.6 5 3.2 10 6.9 13 4.7 II 73 60.3 74 63.2 88 56.4 70 48.6 161 58.1 5 4.1 3 2.6 2 1.3 5 3.5 7 2.5 3 2.5 0 0.0 4 2.6 1 0.7 7 2.5 2 1.7 2 1.7 1 0.6 1 0.7 3 1.1 109 90.1 108 92.3 138 88.5 128 88.9 247 89.2 12 9.9 9 7.7 18 11.5 16 11.1 30 10.8 92 76.0 95 81.2 86 55.1 77 53.5 178 64.3 29 24.0 22 18.8 70 44.9 67 46.5 99 35.7 59 21 17.4 16 13.8 0 0.0 0 0.0 PANSS 60 79 35 28.9 41 35.3 56 35.9 53 36.8 1 80 99 38 31.4 33 28.4 64 41.0 59 41.0 100 120 24 19.8 22 19.0 36 23.1 32 22.2 121 3 2.5 4 3.4 0 0.0 0 0.0 81.5 82.3 87.1 86.7 84.7 SD 21.6 21.7 14.7 15.3 18.2 Min 31 33 61 61 31 83.0 80.0 87.0 87.0 85.0 Max 139 145 120 120 139 PANSS 17 14.0 20 17.1 30 19.2 31 21.5 47 17.0 7 5.8 6 5.1 6 3.8 4 2.8 13 4.7 97 80.2 91 77.8 120 76.9 109 75.7 217 78.3 35

/ 2 /2.7 /CTD LNS LNS HPD LNS RIS n % n % n % n % n % 121 117 156 144 277 3 2.5 1 0.9 1 0.6 0 0.0 4 1.4 22 18.2 19 16.2 31 19.9 26 18.1 53 19.1 53 43.8 54 46.2 76 48.7 69 47.9 129 46.6 25 20.7 28 23.9 26 16.7 29 20.1 51 18.4 4 3.3 2 1.7 3 1.9 6 4.2 7 2.5 1 0.8 3 2.6 2 1.3 1 0.7 3 1.1 1 0.8 0 0.0 0 0.0 0 0.0 1 0.4 0 0.0 1 0.9 4 2.6 0 0.0 4 1.4 12 9.9 9 7.7 13 8.3 13 9.0 25 9.0 LNSHPDRIS #1 PANSS 1 2.7.3.3.1-4 8 II II n % n % n % 80 140 220 46 57.5 76 54.3 122 55.5 34 42.5 64 45.7 98 44.5 < 65 78 97.5 138 98.6 216 98.2 65 2 2.5 2 1.4 4 1.8 39.4 38.6 38.9 SD 13.5 12.1 12.6 Min 18 16 16 Max 72 68 72 58.89 60.18 59.72 kg SD 11.08 11.35 11.24 Min 31.0 37.0 31.0 Max 90.0 95.0 95.0 < 1 7 8.8 9 6.4 16 7.3 1 <2 5 6.3 7 5.0 12 5.5 2 <3 3 3.8 8 5.7 11 5.0 3 <5 8 10.0 17 12.1 25 11.4 5 <10 17 21.3 27 19.3 44 20.0 10 37 46.3 71 50.7 108 49.1 3 3.8 1 0.7 4 1.8 21 26.3 43 30.7 64 29.1 ICD-10 26 32.5 43 30.7 69 31.4 3 3.8 8 5.7 11 5.0 11 13.8 11 7.9 22 10.0 17 21.3 29 20.7 46 20.9 0 0.0 4 2.9 4 1.8 2 2.5 2 1.4 4 1.8 36

/ 2 /2.7 /CTD II II n % n % n % 80 140 220 20 25.0 44 31.4 64 29.1 DSM-III-R 24 30.0 37 26.4 61 27.7 DSM-IV 3 3.8 8 5.7 11 5.0 16 20.0 18 12.9 34 15.5 17 21.3 33 23.6 50 22.7 4 5.0 3 2.1 7 3.2 4 5.0 12 8.6 16 7.3 1 1.3 3 2.1 4 1.8 36 45.0 61 43.6 97 44.1 1 1.3 6 4.3 7 3.2 12 15.0 28 20.0 40 18.2 3 3.8 6 4.3 9 4.1 4 5.0 5 3.6 9 4.1 15 18.8 16 11.4 31 14.1 20 25.0 31 22.1 51 23.2 12 15.0 14 10.0 26 11.8 5 6.3 10 7.1 15 6.8 I 35 43.8 79 56.4 114 51.8 II 5 6.3 4 2.9 9 4.1 1 1.3 1 0.7 2 0.9 2 2.5 1 0.7 3 1.4 68 85.0 117 83.6 185 84.1 12 15.0 23 16.4 35 15.9 58 72.5 110 78.6 168 76.4 22 27.5 30 21.4 52 23.6 89.0 89.0 PANSS SD 22.6 22.6 Min 36 36 87.0 87.0 Max 150 150 PANSS 27 19.3 27 19.3 9 6.4 9 6.4 104 74.3 104 74.3 0 0.0 0 0.0 0 0.0 4 5.0 9 6.4 13 5.9 29 36.3 47 33.6 76 34.5 31 38.8 54 38.6 85 38.6 2 2.5 0 0.0 2 0.9 0 0.0 3 2.1 3 1.4 1 1.3 0 0.0 1 0.5 1 1.3 4 2.9 5 2.3 12 15.0 23 16.4 35 15.9 37

/ 2 /2.7 /CTD 2.7.3.3.1-5 1 2 3 n % n % n % n % 51 61 321 433 32 62.7 28 45.9 200 62.3 260 60.0 19 37.3 33 54.1 121 37.7 173 40.0 < 65 51 100.0 54 88.5 289 90.0 394 91.0 65 0 0.0 7 11.5 32 10.0 39 9.0 40.8 42.5 45.2 44.3 SD 11.3 15.2 14.0 14.0 Min 19 19 16 16 Max 63 71 79 79 58.91 59.91 62.63 61.80 kg SD 11.28 10.75 13.25 12.76 Min 38.0 39.0 36.0 36.0 Max 88.0 90.0 105.0 105.0 < 1 3 5.9 2 3.3 9 2.8 14 3.2 1 <2 2 3.9 6 9.8 14 4.4 22 5.1 2 <3 4 7.8 7 11.5 11 3.4 22 5.1 3 <5 2 3.9 4 6.6 16 5.0 22 5.1 5 <10 12 23.5 12 19.7 38 11.8 62 14.3 10 27 52.9 28 45.9 231 72.0 286 66.1 1 2.0 2 3.3 2 0.6 5 1.2 16 31.4 29 47.5 111 34.6 156 36.0 ICD-10 12 23.5 14 23.0 91 28.3 117 27.0 5 9.8 4 6.6 10 3.1 19 4.4 2 3.9 1 1.6 11 3.4 14 3.2 14 27.5 13 21.3 88 27.4 115 26.6 1 2.0 0 0.0 5 1.6 6 1.4 1 2.0 0 0.0 5 1.6 6 1.4 16 31.4 29 47.5 111 34.6 156 36.0 DSM-III-R 10 19.6 14 23.0 87 27.1 111 25.6 DSM-IV 5 9.8 4 6.6 9 2.8 18 4.2 5 9.8 1 1.6 18 5.6 24 5.5 15 29.4 13 21.3 95 29.6 123 28.4 0 0.0 0 0.0 1 0.3 1 0.2 0 0.0 0 0.0 2 0.6 2 0.5 6 11.8 8 13.1 53 16.5 67 15.5 0 0.0 2 3.3 5 1.6 7 1.6 24 47.1 29 47.5 168 52.3 221 51.0 2 3.9 1 1.6 9 2.8 12 2.8 11 21.6 9 14.8 41 12.8 61 14.1 1 2.0 5 8.2 14 4.4 20 4.6 2 3.9 1 1.6 5 1.6 8 1.8 5 9.8 6 9.8 24 7.5 35 8.1 38

/ 2 /2.7 /CTD 1 2 3 n % n % n % n % 51 61 321 433 13 25.5 18 29.5 62 19.3 93 21.5 7 13.7 9 14.8 25 7.8 41 9.5 2 3.9 2 3.3 15 4.7 19 4.4 I 26 51.0 24 39.3 200 62.3 250 57.7 II 1 2.0 1 1.6 8 2.5 10 2.3 1 2.0 5 8.2 6 1.9 12 2.8 1 2.0 2 3.3 5 1.6 8 1.8 40 78.4 57 93.4 318 99.1 415 95.8 11 21.6 4 6.6 3 0.9 18 4.2 38 74.5 56 91.8 297 92.5 391 90.3 13 25.5 5 8.2 24 7.5 42 9.7 93.0 69.8 79.5 79.7 PANSS SD 23.9 22.2 24.5 24.7 Min 46 30 32 30 87.0 69.0 78.0 79.0 Max 150 117 151 151 PANSS 13 25.5 15 24.6 45 14.1 73 16.9 3 5.9 5 8.2 12 3.8 20 4.6 35 68.6 41 67.2 263 82.2 339 78.5 0 0.0 2 3.3 6 1.9 8 1.8 2 3.9 13 21.3 73 22.7 88 20.3 14 27.5 21 34.4 118 36.8 153 35.3 22 43.1 19 31.1 116 36.1 157 36.3 0 0.0 0 0.0 4 1.2 4 0.9 1 2.0 2 3.3 1 0.3 4 0.9 1 2.0 0 0.0 0 0.0 1 0.2 11 21.6 4 6.6 3 0.9 18 4.2 2.7.3.3.1-6 8 2430% 1 38.5%20/52 3 22.7%73/321 39

/ 2 /2.7 /CTD 2.7.3.3.1-6 % #1 LNS 129 129 31 24.0 HPD 136 134 39 29.1 LNS 156 156 46 29.5 RIS 146 145 #2 37 25.5 II LNS 81 81 21 25.9 II LNS 149 149 41 27.5 1 LNS 52 52 20 38.5 2 LNS 61 61 20 32.8 3 LNS 322 321 73 22.7 LNSHPDRIS #1/ #2 1 2.7.3.3.1-7 2.7.3.3.1-7 1 18 65 2 DSM-IV-TR 3 PANSS 70 4 PANSS 2 4 5 CGI- 4 6 2 1 DSM-IV-TR / 2 PANSS 20% CGI- 1 3 DSM-IV-TR 4 5 6 40

/ 2 /2.7 /CTD 2.7.3.3.2 PANSS BPRS PANSS 1) (1) PANSS a) PANSS PANSS 2.7.3.3.2-1 PANSS 10.6±17.795%12.78.5 7.8±18.295%11.24.411.5±17.495% 14.48.7 III PANSS 10.0±18.495% 13.46.611.1±17.395%13.88.3 PANSS PANSS 11.05±17.27 11.51±17.38 0.46±2.00SE 95% 4.403.487 2.7.3.2-5 2.7.3.3.2-1 PANSS 95% 95% n SD n SD 95% 95% CI-L CI-U CI-L CI-U n SD 95% 95% CI-L CI-U LNS 114-10.0 18.4-13.4-6.6 156-11.1 17.3-13.8-8.3 270-10.6 17.7-12.7-8.5 HPD 111-7.8 18.2-11.2-4.4 111-7.8 18.2-11.2-4.4 RIS 144-11.5 17.4-14.4-8.7 144-11.5 17.4-14.4-8.7 95%CI-L95%95%CI-U95% LNSHPDRIS b) PANSS PANSS 2.7.3.3.2-2 7 2.3±5.895%3.01.6 1.9±5.795%2.90.83.1±5.995%4.02.1 7 3.4±4.695%4.02.9 2.2±5.395%3.21.23.0±4.395%3.72.3 16 4.9±9.395%6.0 41

/ 2 /2.7 /CTD 3.83.7±9.395%5.41.95.5±9.195% 7.03.9 PANSS PANSS 2.7.3.2-6 p = 0.025Wilcoxon 2.7.3.2-3 2.7.3.3.2-2 PANSS 95% 95% 95% 95% n SD n SD CI-L CI-U CI-L CI-U n SD 95% 95% CI-L CI-U LNS 114-1.9 6.1-3.1-0.8 156-2.5 5.5-3.4-1.6 270-2.3 5.8-3.0-1.6 HPD 111-1.9 5.7-2.9-0.8 111-1.9 5.7-2.9-0.8 RIS 144-3.1 5.9-4.0-2.1 144-3.1 5.9-4.0-2.1 LNS 114-3.4 4.7-4.3-2.5 156-3.4 4.6-4.2-2.7 270-3.4 4.6-4.0-2.9 HPD 111-2.2 5.3-3.2-1.2 111-2.2 5.3-3.2-1.2 RIS 144-3.0 4.3-3.7-2.3 144-3.0 4.3-3.7-2.3 LNS 114-4.6 9.5-6.4-2.9 156-5.1 9.1-6.6-3.7 270-4.9 9.3-6.0-3.8 HPD 111-3.7 9.3-5.4-1.9 111-3.7 9.3-5.4-1.9 RIS 144-5.5 9.1-7.0-3.9 144-5.5 9.1-7.0-3.9 95%CI-L95%95%CI-U95% LNSHPDRIS (2) 2.7.3.3.2-3 55.4%153/276 51.3%60/117 56.6%81/143 61.2%74/121 95%51.9 69.9 51.3%60/117 95%41.960.6 = 10%p = 0.001, 2.7.3.2-2 42

/ 2 /2.7 /CTD 2.7.3.3.2-3 n % 95% 95% n % 95% 95% CI-L CI-U CI-L CI-U n % 95% 95% CI-L CI-U LNS 121 74 61.2 51.9 69.9 155 79 51.0 42.8 59.1 276 153 55.4 49.4 61.4 HPD 117 60 51.3 41.9 60.6 117 60 51.3 41.9 60.6 RIS 143 81 56.6 48.1 64.9 143 81 56.6 48.1 64.9 95%CI-L95%95%CI-U95% LNSHPDRIS (3) PANSS PANSS 2.7.3.3.2-1 PANSS 7 75% 1.5 75% 1.5 75% 25% 25% 1.5 25% 1.5 2.7.3.3.2-1 PANSS (4) BPRS BPRS 2.7.3.3.2-4 BPRS 7.1±11.195%8.45.8 5.1±10.695%7.03.17.4±11.295%9.35.6 43

/ 2 /2.7 /CTD 2.7.3.3.2-4 BPRS n SD 95% 95% n SD 95% 95% 95% 95% n SD CI-L CI-U CI-L CI-U CI-L CI-U LNS 121-7.0 11.4-9.1-5.0 156-7.2 11.0-8.9-5.5 277-7.1 11.1-8.4-5.8 HPD 116-5.1 10.6-7.0-3.1 116-5.1 10.6-7.0-3.1 RIS 144-7.4 11.2-9.3-5.6 144-7.4 11.2-9.3-5.6 95%CI-L95%95%CI-U95% LNSHPDRIS BPRS 2.7.3.3.2-5 2.7.3.2-7 III p = 0.022Wilcoxon 2.7.3.2-4 2.7.3.3.2-5 BPRS n SD 95% CI-L 95% CI-U n SD 95% CI-L 95% CI-U n SD 95% CI-L LNS 121-2.2 2.5-2.7-1.8 156-2.2 2.6-2.6-1.8 277-2.2 2.6-2.5-1.9 HPD 116-1.6 2.7-2.1-1.1 116-1.6 2.7-2.1-1.1 RIS 144-2.0 2.7-2.4-1.5 144-2.0 2.7-2.4-1.5 LNS 121-1.1 3.1-1.6-0.5 156-1.4 3.2-2.0-0.9 277-1.3 3.2-1.7-0.9 HPD 116-1.2 3.4-1.8-0.5 116-1.2 3.4-1.8-0.5 RIS 144-1.6 3.3-2.1-1.1 144-1.6 3.3-2.1-1.1 LNS 121-1.9 3.1-2.5-1.4 156-1.6 3.2-2.1-1.1 277-1.8 3.2-2.1-1.4 HPD 116-1.0 3.0-1.5-0.5 116-1.0 3.0-1.5-0.5 RIS 144-1.6 3.6-2.2-1.0 144-1.6 3.6-2.2-1.0 LNS 121-0.8 2.7-1.3-0.3 156-1.0 2.4-1.3-0.6 277-0.9 2.6-1.2-0.6 HPD 116-0.4 2.7-0.9 0.1 116-0.4 2.7-0.9 0.1 RIS 144-1.1 2.5-1.5-0.7 144-1.1 2.5-1.5-0.7 LNS 121-1.0 2.7-1.5-0.5 156-1.0 2.6-1.4-0.6 277-1.0 2.7-1.3-0.7 HPD 116-1.0 2.3-1.4-0.6 116-1.0 2.3-1.4-0.6 RIS 144-1.2 2.9-1.7-0.7 144-1.2 2.9-1.7-0.7 95%CI-L95%95%CI-U95% LNSHPDRIS 95% CI-U 44

/ 2 /2.7 /CTD (5) 2 PANSS 2 PANSS PANSS BPRS PANSS BPRS 2) 8 8 II 2 (1) PANSS II PANSS II PANSS 2.7.3.3.2-6 2.7.3.3.2-6 II PANSS n SD 95% CI-L 95% CI-U 140-11.5 24.2-15.5-7.4 140-2.2 7.1-3.4-1.0 140-4.1 6.2-5.1-3.0 140-5.2 12.9-7.4-3.0 95%CI-L95%95%CI-U95% (2) 8 2.7.3.3.2-7 2.7.3.3.2-7 8 n #1 % 95%CI-L 95%CI-U II 80 38 47.5 36.2 59.0 II 140 68 48.6 40.0 57.2 220 106 48.2 41.4 55.0 95%CI-L95%95%CI-U95% #1 45

/ 2 /2.7 /CTD (3) BPRS 8 BPRS 2.7.3.3.2-8 2.7.3.3.2-9 2.7.3.3.2-8 8 BPRS n SD 95% CI-L 95% CI-U II 80-8.7 14.7-11.9-5.4 II 140-7.3 15.3-9.9-4.8 220-7.8 15.0-9.8-5.8 95%CI-L95%95%CI-U95% 2.7.3.3.2-9 8 BPRS n SD 95% CI-L 95% CI-U II 80-2.7 3.2-3.4-2.0 II 140-2.8 3.5-3.4-2.2 220-2.8 3.4-3.2-2.3 II 80-1.5 3.9-2.4-0.7 II 140-1.6 4.0-2.2-0.9 220-1.6 4.0-2.1-1.0 II 80-2.4 3.9-3.2-1.5 II 140-1.3 4.0-1.9-0.6 220-1.7 4.0-2.2-1.1 II 80-1.0 3.4-1.7-0.2 II 140-0.8 3.5-1.4-0.2 220-0.9 3.5-1.3-0.4 II 80-1.1 3.5-1.9-0.3 II 140-0.9 3.9-1.5-0.2 220-1.0 3.8-1.5-0.5 95%CI-L95%95%CI-U95% (4) 8 PANSSBPRS 8 3) II 2 3 46

/ 2 /2.7 /CTD (1) PANSS PANSS 2.7.3.3.2-10 2.7.3.3.2-11 3 8.7±18.895%10.56.9 8 1 II PANSS 2.7.3.3.1-5 2 23.6±27.2 95%31.515.736.4±16.0 95%8.24.7 10 72.0%231/321 62.3%200/321 2 2.7.3.3.1-5 1 3 2.7.3.3.2-10 PANSS n SD 95%CI-L 95%CI-U 1 48-23.6 27.2-31.5-15.7 2 59-8.8 19.0-13.8-3.9 3 315-6.4 16.0-8.2-4.7 422-8.7 18.8-10.5-6.9 95%CI-L95%95%CI-U95% 2.7.3.3.2-11 PANSS n SD 95% CI-L 95% CI-U 1 48-5.7 7.5-7.9-3.5 2 59-1.7 6.1-3.3-0.1 3 315-0.9 4.8-1.4-0.3 422-1.5 5.6-2.1-1.0 1 48-6.8 7.7-9.0-4.5 2 59-2.9 3.9-3.9-1.9 3 315-2.4 4.5-2.9-1.9 422-3.0 5.1-3.5-2.5 1 48-11.1 14.4-15.3-6.9 2 59-4.3 11.5-7.3-1.3 3 315-3.1 8.7-4.1-2.2 422-4.2 10.2-5.2-3.2 95%CI-L95%95%CI-U95% 47

/ 2 /2.7 /CTD (2) 2.7.3.3.2-12 3 52.4%227/433 8 1 64.7%33/51 II 1 76.0%38/50 2.7.3.2-152 67.2%41/61 PANSS 8.8±19.095%13.83.9 8 2 3 2.7.3.3.1-5 2.7.3.3.2-12 n #1 % 95%CI-L 95%CI-U 1 51 33 64.7 50.1 77.6 2 61 41 67.2 54.0 78.7 3 321 153 47.7 42.1 53.3 433 227 52.4 47.6 57.2 95%CI-L95%95%CI-U95% #1 (3) BPRS BPRS 2.7.3.3.2-13 2.7.3.3.2-14BPRS PANSS 1 2 2.7.3.3.2-13 BPRS n SD 95%CI-L 95%CI-U 1 48-14.9 15.6-19.5-10.4 2 61-5.7 11.6-8.7-2.8 3 320-4.3 10.1-5.4-3.2 429-5.7 11.5-6.8-4.6 95%CI-L95%95%CI-U95% 48

/ 2 /2.7 /CTD 2.7.3.3.2-14 BPRS n SD 95% CI-L 95% CI-U 1 48-4.1 4.0-5.3-3.0 2 61-1.9 2.2-2.4-1.3 3 320-1.8 2.8-2.1-1.4 429-2.0 3.0-2.3-1.8 1 48-3.4 4.3-4.6-2.1 2 61-0.7 3.4-1.5 0.2 3 320-0.7 2.9-1.1-0.4 429-1.0 3.2-1.3-0.7 1 48-2.9 4.1-4.1-1.7 2 61-2.2 3.6-3.1-1.3 3 320-1.1 2.7-1.4-0.8 429-1.5 3.1-1.8-1.2 1 48-2.0 3.6-3.0-0.9 2 61-0.6 2.7-1.3 0.1 3 320-0.4 2.5-0.6-0.1 429-0.6 2.7-0.8-0.3 1 48-2.5 3.5-3.6-1.5 2 61-0.5 2.8-1.2 0.3 3 320-0.4 2.3-0.6-0.1 429-0.6 2.6-0.9-0.4 95%CI-L95%95%CI-U95% (4) 4) a) PANSS ITT PANSS 2.7.3.3.2-15 PANSS 2.7.3.3.2-15 PANSS ITT n #1 SE #2 vs LNS 2.5 mg 60-20.60 3.01 p<0.05 LNS 5 mg 57-27.19 3.07 p<0.05 LNS 10 mg 62-30.18 2.99 p<0.05 HPD 10 mg 58-28.16 3.05 p<0.05 61-12.58 2.97 LNSHPDNSNot significant #1ANCOVA #2Fisher LSDLeast Significance Difference 49

/ 2 /2.7 /CTD PANSS 2.7.3.3.2-16 2.5 mg 2.7.3.3.2-16 PANSS ITT n #1 SE #2 vs LNS 2.5 mg 60-7.21 0.95 p<0.05 LNS 5 mg 57-9.05 0.97 p<0.05 LNS 10 mg 62-10.06 0.94 p<0.05 HPD 10 mg 58-10.64 0.96 p<0.05 61-4.61 0.94 LNS 2.5 mg 60-3.54 0.72 NS LNS 5 mg 57-5.11 0.73 p<0.05 LNS 10 mg 62-5.88 0.71 p<0.05 HPD 10 mg 58-4.13 0.73 NS 61-1.95 0.71 LNSHPDNSNot significant #1ANCOVA #2Fisher LSD b) 6 2.5510 mg / 10 mg / 2.5 mg/ 10 mg / 10 mg/ 10 mg/ 2.7.3.3.3 1) (1) PANSS 2.7.3.3.3-1 2.7.3.3.3-2PANSS 9.3±17.912.4±17.4 8 15.8±24.26.3±23.3 65 11.0±17.865 6.0±16.4 65 9.1±19.565 5.3±8.8 1 50