125 2 P 1st washout 2 PB P mg/dL nd washout 2 P 5.5mg/dL< mg/dL <2.5mg/dL P P 2 D D 3 Ca 10

. (1) 125 1 125 Renagel PB-94 P intact-pth P 1 b c a b 1 18 2 3 3 3 1 P 4 D 1 5 6 7 2 1HIV 2 3 4 5Hb 8.0g/dL ALT 48IU/L 6 7 PB-94 440mg 403mg 1-196

125 2 P 1st washout 2 PB-94 1 2 4 4 P 2.5 5.5mg/dL 1 3 44 2nd washout 2 P 5.5mg/dL< 2.5 5.5mg/dL <2.5mg/dL 1 1 2 3 1 1 2 3 3 1 2 3 1 P P 2 D D 3 Ca 1000 1500mg/ Ca 2 Ca Ca 900mg/1500mg/ 1 Ca P Mg Na K Cl LDH AST ALT T-Bil ALP T-Cho LDL-Cho HDL-Cho TG TPAlb BUN Cr UAHCO 3 Fe TIBCintact-PTH 2 Plt 3 PT APTT 4 A 1,25(OH) 2 D 25(OH)D E 5HCG 60 126 1 1 P 2T-Cho LDL-Cho HDL-Cho TG intact-pth 2 Not RelatedRemotePossibly Related Probably Related Possibly RelatedProbably Related -197

125 200 192 192 p 5 1 2 t intact-pth Wilcoxon 24 126 1st washout 2nd washout -2-1 0 1,2,4 8 12 16 20 24 28 32 36 40 42 44 45 46 1 3 44 P Ca HCG 60-198

1 192 192 2 127 P PB-94 kg P PTx D D Kt/V (n=191) Ca meq/l 127 n=192 Range Mean S.D. Median Range Mean S.D. Median African-American Caucasian Hispanic Asian PB-94 Ca Ca Al Ca Al Range Mean S.D. Median Range Mean S.D. Median 3.0 3.0 % 120 62.5 72 37.5 19.0-86.0 56.1 14.6 56.0 36.8-174.2 8 23.7 77.7 104 54.2 68 35.4 14 7.3 4 2.1 2 65 33.9 57 29.7 27 14.1 5 2.6 38 19.8 101 52.6 36 18.8 24 12.5 3 1 27 14.1 172 89.6 20 10.4 178 92.7 14 7.3-2 3.8 3.7 3.0 49 25.5 143 74.5 16 8.3 127 66.1 0.8-2.2 1.5 0.2 1.5 137 71.4 55 28.6-199

3 192 69 25 12 12 3 1 16 4 D D 192 66 34.4% 21 10.9% 21 10.9% Ca 66 34.4% Ca 13 6.8% 5 84.4% 5.95g/ 5.02g/ 6 1 P Mean S.D. P 62 P 8.66 2.21mg/dL 6.43 1.94mg/dL -2.22 2.40mg/dL t t=-12.864 p<012nd washout P 1.73 1.87mg/dL t t=8.880 p<01 1 9.0 血清 P 濃度 (mg/dl) 8.0 7.0 6.0 5.0 4.0 0 4 8 12 16 20 24 28 32 36 40 44 46 0 4 8 12 16 20 24 28 32 36 40 44 46 ( 週 ) 62 P Mean S.E. -200

2 Ca Mean S.D. Ca 63 Ca 9.09 0.77mg/dL 9.41 0.80mg /dl 0.32 0.88mg/dL t t=5.100 p<01 1 Camg/dL 1 1 9.5 9.0 8.5 8.0 0 0 4 8 12 16 20 24 28 32 36 40 44 46 8 4 8 12 16 20 24 28 32 36 40 44 46 ( 週 ) 63 Ca Mean S.E. 3 Ca P Mean S.D. Ca P 64 Ca P 78.35 19.94 mg/dl 2 60.28 18.00 mg/dl 2-18.08 22.16 mg/dl 2 t t=-105 p<01 80 75 70 Ca P 積 (mg/dl) 2 65 60 55 50 45 40 0 0 4 8 12 16 20 24 28 32 36 40 44 46 8 4 8 12 16 20 24 28 32 36 40 44 46 64 Ca P Mean S.E. -201

4 intact-pth Median intact-pth 128 intact-pth 286.5pg/mL 254.0pg/mL 128 intact-pth pg/ml Wilcoxon n u p 184 286.5 149.5, 481.5 192 254.0 10, 519.0-18.0-13,119.0 0.846 0.399 Median 25,75% 5 129 T-Cho LDL-Cho HDL-Cho TG 129 mg/dl n t t p T-Cho 192 175.3 44.6 147.4 38.2-27.9 35.4-10.897 <01 LDL-Cho 190 106.6 33.8 75.0 29.9-31.5 28.8-15.075 <01 HDL-Cho 190 36.4 13.7 42.3 13.6 5.9 11.2 7.239 <01 TG 192 164.4 123.5 151.9 104.2-12.4 104.4-50 0.100 Mean S.D. -202

7 1 130 131 192 187 97.4% 2383 141 73.4% 378 192 49 25.5% 111 49 58 4 14 7.3% 11 5.7% NOS 8 4.2% 5 1 1 NOS 1 1 NOS 1 130 MedDRA SOC MedDRA PT % * 4 3 4,3 2,1 0 0 0 21 10.9 NOS 0 13 6.8 NOS 0 2 0 1 0 4 2.1 0 1 0 0 0 70 36.5 0 10 5.2 0 1 0 3 NOS 0 4 2.1 0 4 2.1 0 1 0 1 NOS 0 3 0 1 0 12 6.3 NOS 0 5 2.6 0 5 2.6 NOS 0 1 NOS 0 1 0 2 NOS 0 5 2.6 0 1 0 3 0 10 5.2 0 1 0 2 NOS 0 1 0 9 4.7 0 5 2.6 0 2 NOS 0 1 NOS 0 4 2.1 NOS 0 8 4.2 0 1 0 1 NOS 0 8 4.2 NOS 0 1 0 1 0 1 1 0 1 1 0 * 4 Probably Related 3 Possibly Related 2 Remote 1 Not Related -203

MedDRA SOC 130 MedDRA PT % * 4 3 4,3 2,1 0 0 0 11 5.7 NOS 0 1 0 1 0 5 2.6 0 1 0 2 NEC 0 6 3.1 0 1 1 7 3.6 NOS 1 1 2 0 1 0 1 0 1 1 1 2 0 1 1 22 11.5 0 2 NEC 0 1 0 2 NEC 0 3 1 1 0 0 1 0 1 NEC 0 1 0 3 0 2 NOS 0 2 0 2 0 1 0 1 0 4 2.1 1 1 0 NOS 0 1 6 3.1 33 17.2 39 20.3 102 53.1 2 2 3 NOS 0 1 0 1 NOS 3 3 11 5.7 1 5 2.6 6 3.1 15 7.8 0 1 0 3 0 1 NOS 0 1 4 2.1 4 2.1 26 13.5 NOS 7 3.6 7 3.6 41 21.4 NOS 0 1 NOS 0 1 0 1 0 2 11 5.7 11 5.7 23 12.0 1 1 0 1 1 4 2.1 0 1 0 1 2 4 2.1 6 3.1 3 1 1 0 0 2 * 4 Probably Related 3 Possibly Related 2 Remote 1 Not Related -204

130 MedDRA SOC MedDRA PT % * 4 3 4,3 2,1 NOS 0 1 0 2 NOS 0 1 NOS 0 7 3.6 0 2 0 1 0 3 0 1 0 1 0 1 NOS 0 1 1 1 4 2.1 0 1 0 1 0 1 14 7.3 14 7.3 54 28.1 0 1 NOS 0 1 NOS 0 1 1 1 0 0 1 1 1 0 0 1 NOS 0 9 4.7 0 2 0 9 4.7 NOS 0 1 0 2 NOS 1 7 3.6 8 4.2 56 29.2 0 1 0 1 0 2 2 134 69.8 0 45 23.4 NOS 0 2 0 1 NOS 0 1 0 8 4.2 0 12 6.3 0 5 2.6 0 1 NOS 0 1 0 1 NOS 0 6 3.1 0 2 0 3 0 6 3.1 0 20 10.4 0 9 4.7 0 11 5.7 0 4 2.1 0 12 6.3 0 2 0 3 0 5 2.6 0 17 8.9 0 14 7.3 0 2 * 4 Probably Related 3 Possibly Related 2 Remote 1 Not Related -205

130 MedDRA SOC MedDRA PT % * 4 3 4,3 2,1 0 42 21.9 NOS 0 5 2.6 0 5 2.6 1 1 1 NOS 0 19 9.9 0 33 17.2 0 13 6.8 0 1 NOS 0 2 NOS 0 2 1 1 15 7.8 0 2 0 1 0 0 0 2 NOS 0 1 0 1 0 0 0 5 2.6 NOS 0 1 0 1 NOS 0 3 0 2 2 111 57.8 NOS 0 1 NOS 0 3 NOS 0 12 6.3 NOS 0 1 0 10 5.2 0 2 NOS 0 2 NOS 0 1 0 1 NOS 0 1 0 1 NOS 0 3 0 1 0 1 NOS 0 1 NOS 0 2 NOS 0 1 0 2 0 1 NOS 0 8 4.2 1 1 3 0 7 3.6 0 2 0 33 17.2 0 1 0 1 NOS 0 3 NOS 0 2 NOS 0 1 NOS 0 1 0 1 NOS 0 1 NOS 0 8 4.2 NOS 0 1 NOS 0 6 3.1 0 1 * 4 Probably Related 3 Possibly Related 2 Remote 1 Not Related -206

130 MedDRA SOC MedDRA PT % * 4 3 4,3 2,1 NOS 0 5 2.6 0 1 NOS 0 1 NOS 0 3 0 3 NOS 0 24 12.5 0 1 NOS 1 1 9 4.7 0 2 NOS 0 3 NEC 0 2 0 0 0 42 21.9 NOS 0 1 NOS 0 16 8.3 0 6 3.1 NOS 0 1 2 0 1 0 2 0 2 NOS 0 1 NOS 0 1 0 1 0 2 0 2 0 1 0 6 3.1 NOS 0 1 0 1 0 1 0 1 0 3 0 2 0 1 0 1 NOS 0 1 1 3 4 2.1 74 38.5 NOS 0 1 0 2 0 1 0 1 1 1 2 1 1 1 0 1 0 10 5.2 0 3 0 2 0 3 1 1 9 4.7 0 2 0 3 0 1 0 2 0 4 2.1 0 13 6.8 0 5 2.6 0 1 0 1 * 4 Probably Related 3 Possibly Related 2 Remote 1 Not Related -207

130 MedDRA SOC MedDRA PT % * 4 3 4,3 2,1 TG 0 1 0 1 0 1 0 14 7.3 0 1 NOS 0 1 NOS 0 1-0 1 0 7 3.6 0 4 2.1 NOS 0 1 0 1 0 1 0 8 4.2 INR 0 1 NOS 1 1 2 NOS 0 1 0 2 0 1 0 3 0 1 0 1 0 1 0 2 0 1 0 1 NOS 0 1 0 4 2.1 1 1 3 5 2.6 4 2.1 9 4.7 56 29.2 NOS 1 1 5 2.6 0 5 2.6 NOS 2 2 12 6.3 0 1 0 1 2 2 9 4.7 0 4 2.1 1 1 3 NOS 0 5 2.6 0 7 3.6 1 2 3 4 2.1 3 1 4 2.1 13 6.8 NOS 0 4 2.1 0 1 0 2 1 1 1 NOS 0 2 0 1 0 1 NOS 0 1 0 1 1 103 53.6 0 37 19.3 NOS 0 3 1 1 19 9.9 NOS 0 1 0 2 NOS 0 1 * 4 Probably Related 3 Possibly Related 2 Remote 1 Not Related -208

130 MedDRA SOC MedDRA PT % * 4 3 4,3 2,1 0 1 NOS 0 1 0 1 0 46 24.0 NOS 0 1 0 5 2.6 0 5 2.6 0 6 3.1 0 42 21.9 0 1 0 1 0 1 0 2 2 10 5.2 NOS 0 1 NOS 1 1 0 NOS 0 1 0 1 NOS 1 1 4 2.1 0 1 NOS 0 1 0 2 NOS 0 1 0 3 3 99 5 0 1 0 1 NOS 0 2 NOS 0 3 0 1 NOS 0 2 0 1 NEC 0 2 NOS 0 2 0 1 0 1 0 42 21.9 0 1 NOS 0 2 NOS 0 1 NOS 1 1 54 28.1 NOS 0 1 0 1 0 11 5.7 NEC 0 18 9.4 NEC 0 4 2.1 1 1 1 NOS 0 1 NEC 0 4 2.1 NEC 0 1 0 2 0 5 2.6 0 1 0 2 1 1 0 NEC 0 2 0 0 0 25 13.0 0 3 * 4 Probably Related 3 Possibly Related 2 Remote 1 Not Related -209

130 MedDRA SOC MedDRA PT % * 4 3 4,3 2,1 NEC 0 6 3.1 0 3 0 1 NOS 0 1 0 1 NEC 0 4 2.1 0 4 2.1 0 1 NOS 0 1 0 3 0 1 0 3 0 0 0 19 9.9 0 1 NOS 0 1 0 4 2.1 0 1 0 6 3.1 0 1 NOS 0 1 0 1 0 4 2.1 NOS 0 1 0 0 0 9 4.7 0 1 0 1 0 2 NOS 0 1 NOS 0 1 NOS 0 2 0 1 0 4 2.1 4 2.1 115 59.9 NOS 0 1 NOS 0 2 0 16 8.3 0 2 NOS 0 23 12.0 0 5 2.6 0 1 1 1 37 19.3 0 14 7.3 1 1 4 2.1 0 7 3.6 NOS 1 1 50 26.0 0 9 4.7 0 4 2.1 0 1 0 1 NOS 0 2 0 1 0 4 2.1 0 2 0 18 9.4 0 9 4.7 0 17 8.9 0 1 NOS 0 6 3.1 * 4 Probably Related 3 Possibly Related 2 Remote 1 Not Related -210

130 MedDRA SOC MedDRA PT % * 4 3 4,3 2,1 NOS 0 2 1 1 5 2.6 0 5 2.6 0 1 0 2 0 1 0 3 3 72 37.5 NOS 0 2 0 1 0 1 NOS 1 1 7 3.6 0 1 0 1 0 7 3.6 0 1 NEC 0 3 0 1 0 4 2.1 0 7 3.6 0 1 0 3 0 3 0 1 0 9 4.7 0 1 NOS 0 1 0 1 0 3 NOS 2 2 18 9.4 0 1 0 1 0 1 0 1 NOS 0 6 3.1 0 1 NOS 0 1 0 1 0 1 0 4 2.1 0 0 0 66 34.4 0 2 0 1 0 1 0 2 NOS 0 2 0 1 0 1 0 3 0 2 0 1 0 50 26.0 0 3 0 9 4.7 0 4 2.1 0 3 3 83 43.2 0 1 0 7 3.6 * 4 Probably Related 3 Possibly Related 2 Remote 1 Not Related -211

130 MedDRA SOC MedDRA PT % * 4 3 4,3 2,1 0 1 0 1 NOS 0 1 NOS 0 1 NOS 0 1 NOS 0 1 0 3 0 1 0 1 0 1 NOS 0 4 2.1 NOS 0 12 6.3 NOS 0 2 1 1 7 3.6 NOS 1 1 23 12.0 NOS 0 39 20.3 0 1 0 1 NOS 0 1 NOS 0 1 0 2 0 2 1 1 1 NOS 0 1 0 1 NOS 0 4 2.1 0 2 0 1 0 1 0 2 * 4 Probably Related 3 Possibly Related 2 Remote 1 Not Related -212

131 MedDRA SOC MedDRA PT % 49 58 4 111 1 () 1 () NOS 1 () 1 () 1 () 1 () 1 () 1 () 1 () 1 () 2 () 2 () NOS 2 () 1 () 3 () 4 (2.1) 2 () 6 (3.1) 2 () 2 () 4 (2.1) NOS 4 (2.1) 3 () 7 (3.6) 7 (3.6) 3 () 1 () 11 (5.7) 1 () 1 () 1 () 1 () 4 (2.1) 1 () 1 () 6 (3.1) 1 () 1 () 1 () 1 () 5 (2.6) 9 (4.7) 14 (7.3) 1 () 1 () 1 () 1 () NOS 2 () 6 (3.1) 8 (4.2) 1 () 1 () 1 () 1 () 1 () 1 () NOS 1 () 1 () 1 () 1 () 1 () 1 () 1 () 1 () NOS 1 () 1 () 1 () 1 () NOS 1 () 1 () NOS 2 () 2 () 2 () 2 () 1 () 1 () 3 () 3 () 1 () 3 () 4 (2.1) 1 () 1 () 1 () 1 () NOS 1 () 1 () NOS 1 () 1 () NOS 1 () 1 () 1 () 1 () 1 () 1 () 1 () 1 () 1 () 1 () NOS 1 () 1 () 1 () 1 () NOS 1 () 1 () NOS 1 () 1 () 2 () 1 () 1 () NOS 1 () 1 () 1 () 1 () -213

2 132 133 4 48.9 65.2% 1 4 22.4% 5 8 21.1% 11.8 18.0% 4 1 4 8.9% 0.8 5.6% 1 4 7.8% 0.7 4.2% -214

132 MedDRA SOC MedDRA PT 1 4 5 8 9 12 13 16 17 20 21 24 25 28 29 32 33 36 37 40 41 44 112/192 58.3 103/185 55.7 105/180 58.3 102/172 59.3 95/168 56.5 103/158 65.2 90/150 6 86/145 59.3 82/142 57.7 66/135 48.9 79/127 62.2 10 187/192 97.4 300 216 274 231 210 210 196 231 187 136 180 12 2383 2 2 1.1 2 1.1 0 2 1.2 0 2 2 1.4 1 0.7 2 1.5 5 3.9 1 21 10.9 NOS 1 2 1.1 1 1 2 1 0.7 1 0.7 3 2.4 1 13 6.8 NOS 1 1 2 1 0.7 1 1 1 0.7 2 4 2.1 1 0.7 1 9 4.7 9 4.9 14 7.8 10 5.8 6 3.6 11 7.0 8 5.3 7 4.8 5 3.5 4 3.0 9 7.1 1 70 36.5 2 1.1 1 1 3 1.9 2 1 0.7 10 5.2 1 0.7 1 1 1 1 0.8 3 NOS 1 1 1 1 0.8 4 2.1 1 1 1 1 0.7 4 2.1 1 0.7 1 1 0.7 1 NOS 1 1 1 0.7 3 1 1 1 2 1.1 3 1.7 1 3 1.9 1 0.7 1 0.8 12 6.3 NOS 2 2 1 5 2.6 1 1 1 1 0.7 1 0.7 5 2.6 NOS 1 1 NOS 1 1 1 1 0.7 2 NOS 1 1 1 0.7 1 0.7 1 0.8 5 2.6 1 0.7 1 1 1 0.7 1 0.7 3 3 1.7 1 1 1 0.7 1 0.7 2 1.4 1 0.8 10 5.2 1 1 1 1 0.7 2 NOS 1 1 1 2 1.1 1 1 2 1.4 1 0.7 1 0.8 9 4.7 1 1 3 1.7 5 2.6 1 1 0.8 2 NOS 1 1 NOS 1 2 1.1 1 4 2.1 NOS 1 3 1.8 1 1 0.7 1 0.7 1 0.7 8 4.2 1 1 1 1 NOS 3 1 1 1 2 8 4.2 NOS 1 1 1 1 0 0 1 0 0 0 0 0 0 0 0 0 1 1 1 2 1 1 3 1.7 3 1.8 0 1 0.7 0 1 0.7 1 0.7 0 0 11 5.7 NOS 1 1 1 1 1 1 1 1 1 0.7 5 2.6 1 1 1 1 0.7 2 NEC 2 1 1 1 0.7 1 0.7 6 3.1 0 1 2 1.1 1 1 0 2 0 0 0 1 0.8 1 8 4.2 1 1 1 3 NOS 1 1 1 1 1 0.8 1 1 2 3 1 2 1.1 1 3 1.7 4 2.4 3 1.9 6 4.0 1 0.7 1 0.7 2 1.5 1 0.8 1 23 12.0 1 1 0.7 2 NEC 1 1 1 1 0.7 2 NEC 1 1 0.7 1 0.7 3 1 1 1 1 1 1 NEC 1 1 1 1 1 3 1 1 2 NOS 1 0.7 1 0.8 2 2 1.2 2 1 1 1 0.7 1 1 2 1 0.7 4 2.1 1 1 NOS 1 0.7 1 43 22.4 39 21.1 28 15.6 22 12.8 27 16.1 20 12.7 27 18.0 25 17.2 18 12.7 19 14.1 15 11.8 2 141 73.4 3 1 1 0.7 5 2.6 NOS 1 0.8 1 1 1 NOS 3 2 1.1 1 1 1 2 1 0.7 2 1.5 1 0.8 14 7.3 2 2 1.1 5 2.8 4 2.4 2 1 0.7 2 1.4 1 0.7 1 0.7 1 0.8 21 10.9 1 1 1 0.7 2 1.5 3 1 0.7 1 NOS 1 1 4 2.1 4 2.2 5 2.8 4 2.4 2 1 0.7 4 2.8 2 1.4 3 2.2 1 0.8 30 15.6 NOS 9 4.7 6 3.2 7 3.9 5 2.9 1 3 1.9 8 5.3 1 0.7 3 2.1 1 0.7 3 2.4 1 48 25.0 NOS 1 0.7 1-215

132 MedDRA SOC MedDRA PT 1 4 5 8 9 12 13 16 17 20 21 24 25 28 29 32 33 36 37 40 41 44 NOS 1 1 1 1 1 1 0.7 2 10 5.2 2 1.1 4 2.2 2 1.2 3 1.8 3 1.9 3 2.0 4 2.8 1 0.7 2 34 17.7 1 0.7 1 1 1 1 1 0.7 1 0.7 5 2.6 1 0.7 1 1 0.8 1 3 2 1.1 1 1 1 1 0.8 9 4.7 1 1 1 0.7 1 0.7 2 NOS 1 1 1 1 0.7 2 NOS 1 0.7 1 NOS 3 1.7 1 1 0.7 2 1.5 7 3.6 1 0.7 1 2 1 1 1 1 1 3 1 1 1 1 1 1 NOS 1 0.7 1 2 1 1 1 0.8 5 2.6 1 1 1 1 1 0.7 1 11 5.7 14 7.6 6 3.3 9 5.2 6 3.6 2 4 2.7 7 4.8 2 1.4 4 3.0 3 2.4 68 35.4 1 0.7 1 NOS 1 1 NOS 1 1 1 1 1 0.7 1 1 0.7 1 1 1 NOS 2 4 2.2 1 1 0.7 1 0.7 9 4.7 1 0.7 1 0.7 2 1 1 1 1 3 2.1 1 0.7 1 0.8 9 4.7 NOS 1 0.7 1 1 1 0.7 2 NOS 11 5.7 6 3.2 11 6.1 6 3.5 3 1.8 5 3.2 6 4.0 7 4.8 3 2.1 2 1.5 4 3.1 64 33.3 1 1 1 1 32 16.7 20 10.8 33 18.3 29 16.9 23 13.7 34 21.5 22 14.7 25 17.2 25 17.6 10 7.4 21 16.5 0 136 70.8 3 2 1.1 6 3.3 8 4.7 4 2.4 3 1.9 3 2.0 6 4.1 3 2.1 4 3.0 3 2.4 45 23.4 NOS 1 1 0.7 2 1 0.7 1 NOS 1 0.7 1 2 1 1 2 1.2 1 1 0.8 8 4.2 2 1 1 1 2 1 0.7 2 1.4 2 12 6.3 3 1.7 1 0.7 1 0.7 5 2.6 1 1 NOS 1 0.7 1 1 0.7 1 NOS 3 1.7 1 1 1 0.7 6 3.1 1 1 2 1 1 1 3 2 1.1 1 1 1 1 0.7 6 3.1 2 1 1 5 3.2 5 3.5 2 1.5 4 3.1 20 10.4 1 1 1 1 2 1.4 1 0.7 2 9 4.7 1 1 2 1 0.7 1 0.7 2 1.5 3 2.4 11 5.7 2 1 1 0.7 4 2.1 2 2 1.1 2 1.2 2 2 1 0.7 1 0.8 12 6.3 1 1 0.7 2 1 1 1 0.7 3 2 1.1 1 1 1 0.7 5 2.6 3 1 4 2.2 3 1.7 2 1.2 1 0.7 1 0.7 1 0.7 1 0.8 17 8.9 2 1 1 1 4 2.5 1 0.7 1 0.7 2 1.4 1 0.8 14 7.3 1 1 0.7 2 3 3 4 2.2 6 3.5 6 3.6 5 3.2 4 2.7 3 2.1 2 1.4 1 0.7 5 3.9 42 21.9 NOS 1 1 1 1 1 0.7 5 2.6 1 2 1.1 1 1 0.7 5 2.6 1 1 0.7 2 NOS 2 3 1.7 1 4 2.5 3 2.0 4 2.8 2 1.4 19 9.9 5 2.6 4 2.2 3 1.7 6 3.6 3 1.9 3 2.0 3 2.1 4 2.8 2 33 17.2 2 1 2 2 3 2.1 2 1.4 1 0.7 13 6.8 1 1 NOS 1 1 0.7 2 NOS 1 1 2 1 2 1.2 4 2.5 2 1 0.7 2 1.4 4 3.1 16 8.3 1 0.7 1 0.7 2 1 0.7 1 1 0 0 0 0 0 0 0 0 1 0.7 0 0 2 NOS 1 1 1 0.7 1 0 0 0 0 1 3 1.9 0 0 0 0 1 0.8 0 5 2.6 1 1 NOS 1 1 NOS 1 1 1 0.8 3 19 9.9 15 8.1 23 12.8 16 9.3 15 8.9 12 7.6 16 10.7 13 9.0 16 1 11 8.1 11 8.7 0 113 58.9 NOS 1 0.7 1 NOS 1 1 1 3 NOS 2 1.1 4 2.2 1 1 0.7 3 2.1 1 0.8 12 6.3-216

132 MedDRA SOC MedDRA PT 1 4 5 8 9 12 13 16 17 20 21 24 25 28 29 32 33 36 37 40 41 44 NOS 1 1 1 3 1.7 1 1 0.7 4 2.8 10 5.2 1 1 0.7 2 NOS 1 1 0.7 2 NOS 1 0.7 1 1 0.7 1 NOS 1 1 1 0.7 1 NOS 1 1 1 0.7 3 1 0.7 1 1 1 NOS 1 1 1 0.7 1 0.8 2 NOS NOS 1 0.7 1 1 1 2 1 0.8 1 NOS 2 1.1 1 2 2 1.4 1 0.7 8 4.2 3 1 0.8 4 2.1 1 2 3 2.0 1 0.7 7 3.6 1 0.7 1 0.7 2 6 3.1 7 3.8 5 2.8 4 2.3 4 2.4 3 2.0 1 0.7 2 1.5 1 0.8 33 17.2 1 0.7 1 1 0.7 1 NOS 1 1 0.7 1 0.7 3 NOS 1 1 2 NOS 1 0.8 1 NOS 1 0.8 1 1 0.7 1 NOS 1 1 NOS 2 1 1 1 0.7 1 0.7 1 0.7 1 0.8 8 4.2 1 0.7 1 NOS NOS 1 1 1 0.7 3 2.1 6 3.1 1 1 NOS 1 1 1 1 0.7 1 0.7 5 2.6 1 1 NOS 1 1 NOS 2 1.1 1 3 1 1 1 3 NOS 3 3 4 2.2 1 2 1.2 4 2.5 1 0.7 4 3.0 2 24 12.5 1 1 NOS 2 1 2 1.2 1 1 0.7 1 0.7 1 0.7 1 0.8 10 5.2 1 1 0.7 2 NOS 2 1 0.7 3 NEC 1 0.7 1 0.7 2 4 2.1 4 2.2 8 4.4 6 3.5 2 1.2 7 4.4 3 2.0 8 5.5 3 2.1 2 1.5 2 0 42 21.9 NOS 1 0.7 1 NOS 3 1 1 3 1.7 2 1.2 2 3 2.1 1 0.8 16 8.3 1 2 1.2 1 1 0.7 1 0.7 6 3.1 NOS 1 1 2 1 0.7 1 1 1 0.7 2 1 1 0.7 2 NOS 1 1 NOS 1 0.7 1 1 0.8 1 1 1 0.7 2 1 1 0.7 2 1 0.7 1 5 2.8 1 6 3.1 NOS 1 1 1 0.7 1 1 1 1 0.7 1 1 2 3 2 1.1 2 1 0.7 1 1 0.7 1 NOS 1 1 14 7.3 11 5.9 13 7.2 10 5.8 10 6.0 9 5.7 7 4.7 13 9.0 8 5.6 9 6.7 12 9.4 1 78 4 NOS 1 0.8 1 1 1 2 1 0.7 1 1 1 1 1 1 0.7 3 1 1 2 1 0.8 1 1 2 1.1 2 1.1 1 3 2.1 1 0.7 10 5.2 1 1 1 3 1 1 0.7 2 1 1 0.7 1 0.7 3 4 2.1 4 2.3 1 1 0.7 10 5.2-217

132 MedDRA SOC MedDRA PT 1 4 5 8 9 12 13 16 17 20 21 24 25 28 29 32 33 36 37 40 41 44 1 1 2 1 1 1 0.7 3 1 1 1 1 0.7 2 1 2 1.1 1 0.7 4 2.1 2 1 1 2 1.2 1 0.7 1 0.7 2 1.4 1 0.7 2 13 6.8 1 1 1 0.7 2 5 2.6 1 0.8 1 1 0.8 1 TG 1 1 1 0.8 1 1 0.7 1 1 1 2 2 3 2.1 2 1.4 2 1.5 1 0.8 14 7.3 1 0.7 1 NOS 1 1 NOS 1 1-1 1 1 1 1 2 1.2 1 0.7 1 0.7 7 3.6 2 1 1 0.7 4 2.1 1 0.7 1 NOS 1 1 1 0.7 1 1 1 2 1.2 1 2 1 0.7 8 4.2 1 0.7 1 NOS 1 1 1 0.7 3 1 0.8 1 NOS 1 1 0.7 2 1 1 1 1 0.7 1 0.8 3 1 0.7 1 1 0.8 1 1 1 2 2 1 1 1 1 NOS 1 1 1 1 2 1.2 4 2.1 1 1 1 1 0.7 4 2.1 11 5.7 8 4.3 7 3.9 2 1.2 7 4.2 6 3.8 6 4.0 16 1 7 4.9 3 2.2 8 6.3 0 65 33.9 NOS 1 1 1 1 0.7 1 0.7 1 0.7 6 3.1 1 3 2.1 1 0.7 5 2.6 NOS 1 1 1 3 1.9 6 4.1 2 1.4 14 7.3 1 0.7 1 1 1 2 1 3 2.0 2 1.4 1 0.7 2 11 5.7 1 1 0.7 1 0.7 1 0.8 4 2.1 1 1 1 0.7 1 0.7 4 2.1 NOS 2 1 1 1 0.7 5 2.6 1 1 1 2 1.4 2 7 3.6 2 1 2 1.1 1 0.7 1 0.8 7 3.6 4 2.1 3 1 1 5 3.0 1 0.7 1 0.7 1 0.7 17 8.9 NOS 1 1 1 1 0.7 4 2.1 1 0.7 1 1 1 0.7 2 1 1 0.7 2 NOS 2 2 1 1 1 1 1 1 NOS 22 11.5 15 8.1 16 8.9 19 1 14 8.3 17 10.8 12 8.0 11 7.6 14 9.9 8 5.9 12 9.4 1 104 54.2 4 2.1 3 8 4.4 4 2.3 4 2.4 2 2 5 3.4 3 2.1 1 0.7 1 0.8 37 19.3 NOS 2 1.1 1 0.7 3 5 2.6 1 1 1 2 1 0.7 2 1.4 3 2.2 3 2.4 1 20 10.4 NOS 1 1 1 0.7 1 0.7 2 NOS 1 1 1 1 NOS 1 1 1 1 3 8 4.3 3 1.7 9 5.2 6 3.6 9 5.7 3 2.0 1 0.7 2 1.5 2 46 24.0 NOS 1 0.8 1 1 1 1 0.7 1 0.7 1 0.8 5 2.6 1 1 1 0.7 1 0.7 1 0.7 5 2.6 1 1 1 0.7 2 1.4 1 0.7 6 3.1 8 4.2 3 3 1.7 3 1.7 4 2.4 5 3.2 2 2 1.4 7 4.9 1 0.7 4 3.1 42 21.9 1 0.7 1-218

132 MedDRA SOC MedDRA PT 1 4 5 8 9 12 13 16 17 20 21 24 25 28 29 32 33 36 37 40 41 44 1 0.7 1 1 0.7 1 4 2.1 1 2 1.1 0 3 1.8 1 1 0.7 0 0 1 0.7 0 0 12 6.3 NOS 1 1 NOS 1 1 NOS 1 1 1 1 NOS 2 1 2 1.1 5 2.6 1 1 NOS 1 1 1 0.7 1 0.7 2 NOS 1 1 12 6.3 12 6.5 20 11.1 22 12.8 11 6.5 13 8.2 18 12.0 16 1 16 1 8 5.9 12 9.4 0 102 53.1 1 1 1 1 NOS 1 1 0.7 2 NOS 2 1.1 1 0.7 3 1 1 NOS 1 1 2 1 1 NEC 2 1.1 2 NOS 1 1 0.7 2 1 1 1 1 1 4 2.2 2 1.1 6 3.5 3 1.8 1 5 3.3 8 5.5 3 2.1 2 1.5 7 5.5 42 21.9 1 0.7 1 NOS 1 1 0.7 2 NOS 1 0.7 1 NOS 5 2.6 5 2.7 7 3.9 9 5.2 2 1.2 6 3.8 5 3.3 2 1.4 6 4.2 6 4.4 2 55 28.6 NOS 1 0.7 1 1 1 1 3 1.7 1 1 2 1 0.7 1 0.7 1 0.8 11 5.7 NEC 1 2 1.1 3 1.7 3 1.8 2 2 1.4 3 2.1 2 18 9.4 NEC 1 2 1.2 1 0.7 4 2.1 1 1 2 NOS 1 1 NEC 1 1 1 0.7 1 0.7 4 2.1 1 1 NEC 1 1 0.7 2 1 2 1.4 2 5 2.6 1 1 1 0.7 1 0.7 2 1 1 NEC 1 1 0.7 2 1 1 6 3.3 3 1.7 4 2.4 2 0 4 2.8 3 2.1 3 2.2 1 0.8 0 25 13.0 1 1 1 0.7 3 NEC 2 1.1 3 1.8 1 0.7 6 3.1 1 1 1 0.7 3 1 0.7 1 NOS 1 1 1 1 NEC 2 1.2 1 0.7 1 0.8 4 2.1 1 1 1 0.7 1 0.7 4 2.1 1 0.7 1 NOS 1 1 1 1 0.7 1 0.7 3 1 1 1 1 0.7 1 0.7 3 3 1 1 1 0 2 4 2.7 0 3 2.1 3 2.2 1 0.8 0 19 9.9 1 1 NOS 1 1 1 1 0.7 1 0.7 1 0.7 4 2.1 1 0.7 1 1 2 2 1 0.7 6 3.1 1 0.7 1 NOS 1 0.7 1 1 0.7 1 1 1 1 0.7 1 0.8 4 2.1 NOS 1 1 0 0 3 1.7 0 0 3 1.9 2 0 0 0 1 0.8 0 9 4.7 1 0.8 1 1 0.7 1 1 1 2 NOS 1 1 NOS 1 0.7 1 NOS 1 1 2 1 1 24 12.5 17 9.2 20 11.1 29 16.9 19 1 16 10.1 16 10.7 23 15.9 19 13.4 13 9.6 17 13.4 2 119 62.0 NOS 1 1 NOS 1 1 2 1 2 1.1 2 1.2 1 4 2.5 1 0.7 1 0.7 1 0.7 1 0.7 2 16 8.3 1 1 0.7 2 NOS 2 1 1 4 2.3 3 1.8 5 3.2 1 0.7 4 2.8 1 0.7 1 0.8 23 12.0 2 1.1 1 2 1.4 5 2.6 1 0.8 1-219

132 MedDRA SOC MedDRA PT 1 4 5 8 9 12 13 16 17 20 21 24 25 28 29 32 33 36 37 40 41 44 4 2.1 5 2.8 6 3.5 5 3.0 3 1.9 2 4 2.8 2 1.4 3 2.2 4 3.1 38 19.8 1 2 1.1 3 1.7 3 1.8 1 0.7 1 0.7 3 2.4 14 7.3 1 1 3 2.1 5 2.6 2 1.1 1 1 1 0.7 1 0.7 1 0.7 7 3.6 NOS 7 3.6 3 7 3.9 8 4.7 3 1.8 3 1.9 5 3.3 5 3.4 4 2.8 3 2.2 3 2.4 51 26.6 2 1 2 1.2 1 0.7 1 0.7 2 1.5 9 4.7 1 1 1 0.7 1 0.7 4 2.1 1 1 1 1 NOS 1 1 2 1 1 2 1 0.7 1 0.7 4 2.1 1 1 2 1 2 1.1 1 2 1.2 2 2 1.4 2 1.4 2 1.5 4 3.1 18 9.4 1 2 1.2 1 1 0.7 1 0.7 1 0.7 1 0.7 1 0.8 9 4.7 4 2.2 2 1.1 3 1.7 1 2 1 0.7 1 0.7 2 1.4 1 0.7 17 8.9 1 1 NOS 1 1 2 2 1.4 6 3.1 1 1 0.7 2 NOS 2 1 1 1 0.7 1 0.7 6 3.1 2 1 1 0.7 1 0.8 5 2.6 1 0.7 1 1 1 0.7 2 1 1 9 4.7 10 5.4 8 4.4 8 4.7 10 6.0 9 5.7 9 6.0 6 4.1 8 5.6 4 3.0 13 10.2 0 75 39.1 NOS 1 1 0.8 2 1 1 1 0.7 1 NOS 1 1 1 2 1.2 1 2 8 4.2 1 1 1 0.7 1 1 1 1 1 0.7 1 0.7 2 7 3.6 1 1 NEC 1 1 0.7 1 0.8 3 1 1 1 1 0.7 2 4 2.1 2 2 2 1 0.7 7 3.6 1 0.7 1 1 1 0.7 1 0.8 3 1 1 1 3 1 1 1 1 2 1 0.7 1 0.7 3 2.2 9 4.7 1 0.7 1 NOS 1 0.7 1 1 0.7 1 1 1 1 0.7 3 NOS 2 3 2 1.1 1 5 3.0 1 2 2 1.4 2 20 10.4 1 1 1 1 1 0.7 1 1 0.7 1 NOS 1 1 1 3 2.4 6 3.1 1 0.7 1 NOS 1 1 1 1 1 0.7 1 1 2 1.2 1 4 2.1 15 7.8 9 4.9 7 3.9 7 4.1 5 3.0 7 4.4 5 3.3 9 6.2 3 2.1 4 3.0 6 4.7 0 66 34.4 1 1 2 1 1 1 1 1 1 2 NOS 1 1 0.7 2 1 1 1 0.7 1 1 2 3 1 1 2 1 1 13 6.8 6 3.2 4 2.2 5 2.9 3 1.8 2 2 6 4.1 1 0.7 3 2.2 5 3.9 50 26.0 1 1 0.7 1 0.8 3 2 1.1 1 2 1 0.7 1 0.7 1 0.7 1 0.7 9 4.7 1 1 1 0.7 1 0.7 4 2.1 21 10.9 13 7.0 11 6.1 6 3.5 11 6.5 10 6.3 8 5.3 12 8.3 10 7.0 8 5.9 9 7.1 1 86 44.8 1 1 1 1 1 1 3 2.0 7 3.6 1 1 1 1 NOS 1 0.8 1 NOS 1 1 NOS 1 0.7 1 NOS 1 0.7 1 1 1 1 0.7 3 1 1 1 0.7 1 1 0.7 1 NOS 1 1 1 0.7 1 0.7 4 2.1 NOS 2 1 4 2.8 2 1.4 2 1.5 1 0.8 12 6.3-220

132 MedDRA SOC MedDRA PT 1 4 5 8 9 12 13 16 17 20 21 24 25 28 29 32 33 36 37 40 41 44 NOS 1 1 2 1 2 1.2 1 0.7 1 0.7 1 0.7 2 8 4.2 NOS 4 2.1 4 2.2 4 2.2 1 1 2 1 0.7 2 1.4 2 1.5 3 2.4 24 12.5 NOS 9 4.7 5 2.7 5 2.8 3 1.7 3 1.8 2 2 2 1.4 3 2.1 3 2.2 2 39 20.3 1 1 1 1 NOS 1 1 NOS 1 0.7 1 2 1.1 2 1 0.7 1 2 1 1 0.7 2 NOS 1 1 1 1 NOS 3 1 4 2.1 1 0.7 1 0.7 2 1 0.7 1 1 1 1 1 0.7 2 133 MedDRA SOC MedDRA PT 1 4 5 8 9 12 13 16 17 20 21 24 25 28 29 32 33 36 37 40 41 44 17/192 8.9 10/185 5.4 10/180 5.6 5/172 2.9 9/168 5.4 8/158 5.1 4/150 2.7 7/145 4.8 5/142 3.5 6/135 4.4 1/127 0.8 1 49/192 25.5 24 13 16 6 13 9 4 10 5 8 1 2 111 0 0 0 0 0 0 0 0 1 0.7 0 0 0 1 1 0.7 1 0 0 1 0 1 0 0 0 0 0 0 0 1 1 1 NOS 1 1 0 0 0 0 0 0 0 0 0 0 0 1 1 1 1 1 1 15 7.8 7 3.8 7 3.9 3 1.7 7 4.2 3 1.9 3 2.0 4 2.8 1 0.7 4 3.0 1 0.8 0 39 20.3 2 2 NOS 1 1 1 3 1 1 1 1 0.7 1 0.7 1 0.7 6 3.1 2 1.1 1 1 0.7 4 2.1 NOS 2 2 1.1 1 1 0.7 1 0.8 7 3.6 5 2.6 2 1.1 1 1 2 1.4 11 5.7 1 0.7 1 1 1 2 2 1.1 1 1 6 3.1 1 1 1 1 3 4 2.2 1 1 2 1.2 1 1 0.7 1 0.7 14 7.3 1 1 1 0.7 1 NOS 1 2 1.1 1 2 1.2 1 1 0.7 8 4.2 0 0 0 0 0 1 0 1 0.7 0 0 0 0 2 1 0.7 1 1 1 1 0 0 0 0 0 0 1 0.7 0 0 0 0 2 1 1 NOS 1 0.7 1 0 0 0 1 1 1 0 1 0.7 0 1 0.7 0 0 4 2.1 1 1 1 1 1 0.7 1 NOS 1 1 1 0.7 1 0 2 1.1 2 1.1 0 2 1.2 2 1 0.7 1 0.7 2 1.4 1 0.7 0 0 9 4.7 NOS 1 0.7 1 NOS 1 1 2 1 1 0.7 2 1 1 1 2 1.1 3 1 1 1 0.7 1 0.7 4 2.1 1 0.7 1 1 0 0 0 0 0 0 0 0 0 0 0 1 1 1 0 0 1 0 0 1 0 0 0 0 0 0 2 NOS 1 1 NOS 1 1 1 0 1 1 0 0 0 0 0 0 0 0 3 NOS 1 1 1 1 1 1 0 0 0 0 1 0 0 0 1 0.7 2 1.5 0 0 4 2.1 1 0.7 1 1 1 NOS 1 0.7 1 1 0.7 1 1 1 1 0 0 0 0 0 0 0 0 0 3 NOS 1 1 NOS 1 1 2 0 0 0 0 1 0 0 2 1.4 0 0 0 0 3 1 0.7 1 NOS 1 0.7 1 1 1-221

3 192 1st washout 5 2.6% 6 86 44.8% 154 2nd washout 18 9.4% 24 Remote Not Related 2 1 NOS 1 4 2.1% Not Related 16 8.3%2 NOS 2 2 2 NOS 1 1 1 NOS NOS NOS NOS 1 NOS NOS NOS 1 1 1 Not Related 4 134 Na UA BUN Cr Hb MCHC WBC Lympho Plt A 25(OH)D E Cl HCO 3 Mg FeALP MCV 1,25(OH) 2 D 134 t t p RBC 10 4 /µl 192 356.0 ± 47.3 348.9 ± 49.2-7.1 ± 52.4-1.888 61 MCV fl 184 91.93 ± 6.71 92.76 ± 7.48 0.83 ± 4.60 2.437 16 MCH pg 184 30.49 ± 2.56 30.39 ± 2.82-0.10 ± 1.70-0.762 0.447 MCHC % 184 33.14 ± 1 32.73 ± 5-0.41 ± 9-5.074 <01 Hb g/dl 192 10.78 ± 1.26 13 ± 2-0.25 ± 1.50-2.289 23 Ht % 192 32.53 ± 3.76 32.19 ± 4.07-0.34 ± 4.62-16 0.311 Plt 10 4 /µl 192 22.11 ± 6.99 20.38 ± 6.85-1.73 ± 5.05-4.752 <01 WBC /µl 192 7456.8 ± 2664.6 7173.4 ± 2602.4-283.3 ± 1921.4-2.043 42 Neu % 190 60.90 ± 12.48 62.24 ± 12.61 5 ± 12.39 1.497 0.136 Lympho % 190 25.09 ± 10.39 23.55 ± 9.31-1.55 ± 9.66-2.209 28 Mono % 190 6.94 ± 2.76 7.33 ± 2.94 0.39 ± 3.24 60 98 Eosino % 190 6.13 ± 4.22 6.11 ± 6.92-2 ± 5.38-50 0.960 Baso % 190 9 ± 2 3 ± 7-7 ± 0.74-1.215 0.226 Alb g/dl 192 3.81 ± 0.26 3.78 ± 0.33-3 ± 0.24-1.447 0.149 TP g/dl 192 7.13 ± 6 7.08 ± 9-5 ± 0.47-1.484 0.139 mg/dl 77 35.97 ± 7.47 36.77 ± 8.23 0.79 ± 5.51 1.262 0.211 g/dl 192 3.32 ± 7 3.30 ± 7-3 ± 0.39-0.898 0.370 AST IU/L 192 14.3 ± 8.9 14.6 ± 9.1 0.2 ± 8.6 0.368 0.713 ALT IU/L 192 13.2 ± 9.6 14.2 ± 22.0 ± 23.2 01 49 LDH IU/L 192 17 ± 38.5 169.0 ± 48.3 - ± 45.4-0.474 36-222

134 t t p ALP IU/L 190 93.1 ± 64.8 125.4 ± 105.0 32.3 ± 72.6 6.133 <01 T-Bil mg/dl 184 3 ± 0.18 4 ± 0.20 1 ± 0.17 0.886 0.377 BUN mg/dl 192 73.59 ± 18.88 66.93 ± 21.11-6.66 ± 20.90-4.416 <01 Cr mg/dl 192 11.91 ± 3.41 14 ± 3.27-8 ± 2.32-3.447 01 UA mg/dl 192 7.11 ± 0 6.32 ± 1.45-0.79 ± 1.28-8.607 <01 Na meq/l 192 139.3 ± 3.1 138.7 ± 3.3 - ± 3.4-2.259 25 K meq/l 192 4.87 ± 0.70 4.97 ± 5 0.10 ± 0.84 95 92 Cl meq/l 192 99.5 ± 4.2 100.8 ± 4.3 ± 4.2 4.231 <01 Mg mg/dl 184 2.51 ± 0.45 2.61 ± 0.49 0.10 ± 0.36 3.738 <01 HCO 3 meq/l 192 17.05 ± 3.82 18.35 ± 4.18 0 ± 4.77 3.767 <01 mg/dl 192 135.1 ± 74.3 125.4 ± 49.2-9.7 ± 63.7-2.115 36 PT 192 13.39 ± 2.34 13.75 ± 4.54 0.36 ± 4.22 1.182 0.239 APTT 190 34.90 ± 8.07 35.30 ± 11.76 0.40 ± 13.16 0.419 76 Fe µg/dl 192 75.8 ± 6 92.7 ± 78.1 16.9 ± 97.8 2.392 18 TIBC µg/dl 192 272.4 ± 75.3 273.7 ± 95.1 ± 109.4 0.164 0.870 % 192 26.56 ± 14.00 32.30 ± 17.59 5.74 ± 19.91 3.994 <01 ng/ml 161 275.0 ± 258.0 414.8 ± 367.0 139.8 ± 288.4 6.148 <01 ng/ml 33 8.94 ± 4.96 7.85 ± 4.87-9 ± 3.43-1.820 78 A ng/ml 183 1713.3 ± 728.8 1567.2 ± 615.6-146.1 ± 63-3.134 02 1,25(OH) 2 D pg/ml 131 13 ± 6.77 18.49 ± 9.91 6.85 ± 10.28 7.632 <01 25(OH)D ng/ml 156 32.66 ± 20.15 26.18 ± 18.40-6.48 ± 16.19-4.998 <01 E mg/dl 183 1.448 ± 74 39 ± 52-0.109 ± 31-2.768 06 Mean±S.D. 8 P Ca T-Cho LDL-Cho -223

(2) b 135 2 135 b Renagel PB-94 P intact-pth P 1 1 18 2 3 3 3 1 P 4 D 1 5 6 2 1HIV 2 3 4 5 1 5 1 1 6 30 7 8 9 10Hb 8.0g/dL ALT 48IU/L 11 12 13 PB-94 14 PB-94 440mg 1 2 P 1st washout 2 1st washout P 6.0mg/dL PB-94 1st washout P -224

135 b P 6.0mg/dL< <7.5mg/dL 7.5mg/dL <9.0mg/dL 9.0mg/dL 1 2 1 3 1 3 1 3 1 4 1 3 2 P 2.5 5.5mg/dL 1 3 8 1 P 5.5mg/dL< 2.5 5.5mg/dL <2.5mg/dL 1 1 1 1 2 3 3 1 2 3 1 P P 2 D D Ca 3 Ca Ca 4 2nd washout 2 1 Ca P Mg Na K Cl LDH AST ALT T-Bil ALP ALP T-Cho LDL-Cho HDL-Cho TG TPAlb Fe TIBCBUN Cr UAHCO 3 intact-pth 2 Plt 3 PT APTT 4 A D E 5 HCG 136 1 1 P 2T-Cho LDL-Cho HDL-Cho TG intact-pth 2 Not RelatedRemotePossibly Related Probably Related Possibly RelatedProbably Related -225

135 b 180 172 172 p 5 1 2 Wilcoxon 3 2 Wilcoxon 16 136 1st washout 2nd washout -2-1 0 1 2 3 4 5 6 7 8 9 10 1 3 8 P Ca intact-pth HCG 1 172 65 172 4 168 ITT 8 26 70% 25 D 8 Ca Ca 2 61 107 PC -226

172 172 ITT 168 ITT 4 PC 107 PC 61 65 2 ITT 137 137 n=168 kg P PTx % 110(65.5) 58(34.5) Range 18.0-86.0 Mean±S.D. 53.1 15.9 Median 52.0 Range 25.3-175.0 Mean±S.D. 8 23.1 Median 77.3 African-American 88 52.4 Caucasian 55 32.7 Hispanic 23 13.7 Asian 1 1 52 3 38 22.6 23 13.7 7 4.2 48 28.6 Ca 82 48.8 Ca 59 35.1 Al 14 8.3 Al Ca 4 2.4 Al Ca 4 2.4 5 3.0 149 88.7 19 1 155 92.3 13 7.7-227

137 % Range <-2 Mean±S.D. 3.6 3.6 Median 3.0 D 81 48.2 87 51.8 D 4 2.4 83 49.4 Range 0.8-2.9 Kt/V Mean±S.D. 1.4 0.3 Median 1.4 2.0 13 7.7 Ca 2.5 96 57.1 meq/l 3.0 42 25.0 3.5 17 10.1 3 85.1%4.98 1.91g/Mean S.D.1 465mg hydrous 4 1 P Mean S.D. P 66 P 9.1 2.4mg/dL 6.6 1.9mg/dL -2.5 2.3mg/dL Wilcoxon p<01 66 P Mean S.E. -228

32 P 2 P PC P P 138 P P P P 138 P P PC n=107 /g/ n P Mean S.D. 4 5 1.86 2.33 6-1.70 0.88 6 9 2.79 4.19 25-2.55 1.24 10 14 4.65 6.51 41-3.78 1.86 15 18 6.98 8.37 21-4.38 2.45 1 19 3 139 P 1st washout 5.5mg/dL 168 136 8% 3 168 124 73.8%6.98g/15cap/ 6 8.37g/18cap/ 168 132 78.6% Kaplan- Meier product limit curve 5.12g/ 50% 139 ITT n=168 / g/ 6 7 9 10 12 13 15 16 18 19 2.79 3.26 4.19 4.65 5.58 6.05 6.98 7.44 8.37 8.84 n % n % n % n % n % n % n % 1 46 27.4 13 7.7 18 10.7 13 7.7 1 0 1 2 23 13.7 7 4.2 9 5.4 7 4.2 0 0 0 3 23 13.7 5 3.0 5 3.0 7 4.2 5 3.0 0 1 4 19 1 1 6 3.6 7 4.2 4 2.4 1 0 5 12 7.1 3 1.8 2 1.2 1 6 3.6 0 0 6 7 4.2 0 1 0 3 1.8 3 1.8 0 7 3 1.8 0 0 0 2 1.2 0 1 8 3 1.8 0 0 0 1 1 1 136 8 29 17.3 41 24.4 35 20.8 22 13.1 5 3.0 4 2.4-229

4 Ca Mean S.D. Ca 67 Ca 9.1 0.8mg/dL 9.4 0.9mg/dL 0.3 mg/dl Wilcoxon p<01 1st washout 67 Ca Mean S.E. 5 intact-pth Mean±S.D. intact-pth 140 intact-pth 449.9 419.6pg/mL 354.6 385.0pg/mL n 140 intact-pth pg/ml Median(25,75%) Mean±S.D. Mean S.D. Wilcoxon p 1st washout 150 208.0 74.0,386.0 332.5±381.1 167 316.0 173.0,522.0 449.9±419.6 2 162 242.5 126.0,454.0 366.5±385.1-77.4±169.3 <01 4 166 24 114.0,487.0 369.7±381.5-73.3±165.9 <01 6 166 218.0 11,453.0 347.2±361.5-97.0±213.5 <01 167 224.0 115.0,418.0 354.6±385.0-9±221.5 <01-230

6 141 T-Cho LDL-Cho HDL-Cho TG 141 mg/dl n Wilcoxon p T-Cho 166 17±43.1 145.0±38.7-25.9±28.2 <01 LDL-Cho 162 102.0±34.9 75.6±29.4-26.4±26.4 <01 HDL-Cho 163 35.3±12.9 35.4±13.3 ±7.9 0.911 TG 166 169.9±137.0 173.3±138.6 2.8±90.1 85 Mean S.D. 5 Coding Symbols for Thesaurus of Advers Reaction Terms COSTART Third Edition 1 172 130 75.6% 499 74 43.0% 135 22 12.8% 22 20 1% 27 16 9.3% 20 12 7.0% 16 12 7.0% 13 142 43 25.0% 81 39 22.7% 60 11 6.4% 11 10 5.8% 10 8 4.7% 11 7 4.1% 8 6 3.5% 7 142 n % 172 43 25.0 81 11 6.4 10 5.8 8 4.7 7 4.1 6 3.5 5 2.9 5 2.9 3 1.7 2 1.2 2 1.2 1 1 1 1-231

142 n % Hb 1 1 1 1 1 1 1 1 1 2 172 1st washout 2 1.2% 2 29 16.9% 33 2nd washout 8 4.7% 9 Not Related Remotely Related 3 1.7%1st washout 1 2nd washout 1 1 1 Not Related 3 Na UA LDH TP ALP-2 BUN Cr Ht RBC Lympho PT INR A 25 OH D Cl Mg TIBC ALP MCH MCHC Neu 6 P Ca 1st washout intact-pth T-Cho LDL-Cho -232

(3) 143 3 143 Ca Ca Renagel PB-94 P Ca P intact-pth Ca Ca P intact-pth OC ALP ICTP P 1 1 19 2 3 3 3 P 4 D 12 5 6 7 8 1 P 8.0mg/dL 9 PB-94 Ca Ca 10 11 1 2 1HIV 2 3 4 1 5 1 1 5 136kg 6 30 7 8 9-233

143 10Hb8.0g/dL ALT 3 11 12 1 PB-94 1 PB-94 800mg 2 Ca 1 500mg 3 1 667mg 1 2 P washout 2 washout 1 P 5.5mg/dL PB-94 P 12 3 4 P 3.0 5.0mg/dL Ca 1mg/dL 1 3 52 P 3.0mg/dL 1 1 2 3 3 1 2 3 1 P P 2 D 12 D intact-pth 300pg/mL D 3 Ca Ca 8.5mg/dL 24 D 3 intact-pth 300pg/mL Ca 4 1 Ca P Mg Na K Cl LDH AST ALT T-Bil ALP ALP OC ICTP T-Cho LDL-Cho HDL-Cho TG TPAlb BUN Cr UAHCO 3 Fe TIBCintact-PTH 2 Plt 3 PT APTT -234

143 4HCG 5 Electron Beam Tomography EBT 1 EBT X helical CT CT EBT X CT X 1 100msec 0.1 EBT 2 EBT Imatron C-100 C-150 EBT R-R 60 80%1 0.1 1 3mm 36 40 3 EBT CT 130Hounsefield Units HU 1 CT 130HU 3 3mm 2 Calcification volume Agatston score R-4 Calcification volume EBT Agatston score Calcification volume CT 130 199 1 200 299 2 300 399 3 400 4 Calcification volume Agatston score Calcification volume Agatston score Calcification volume Agatston score R-5 1 2 Calcification volume Agatston score EBT EBT EBT R-6-235

143 1 Calcification volume/agatston score Calcification volume Agatston score None 0 Mild/Moderate 1-400 Severe 401-1000 Very Severe >1000 2 Calcification volume/agatston score Calcification volume Agatston score None 0 First tirtile Low Second tirtile Middle Third tirtile High 144 1 1 P Ca P intact-pth 2 Ca Ca Ca 1mg/dL 1mg/dL P P 5.0mg/dL intact-pth 150 300pg/mL 2 Not RelatedRemotePossibly Related Probably Related Possibly RelatedProbably Related 100 200 202 PB-94 100 102 202 p 5 1 Fisher Wilcoxon -236

143 2 Wilcoxon Wilcoxon P Ca intact-pth Fisher 3 Fisher Wilcoxon 15 washout 144-2 -1 0 12 16 20 24 26 28 32 36 40 44 48 52 1 3 52 P Ca intact-pth ALP OC ICTP HCG EBT -237

1 202 PB-94 100 102 68 PB-94 1 PB-94 99 101 70% PB-94 23 20 PB-94 76 81 202 PB-94 100 102 200 2 PB-94 99 101 PB-94 1 1 157 43 PB-94 76 81 PB-94 23 20 68-238

2 145 145 n=200 PB-94 n=99 n=101 n=200 63 63.6 67 66.3 130 65.0 36 36.4 34 33.7 70 35.0 Range 22-87 19-82 19-87 Mean 56.98 56.17 56.57 Median 59 58 58 Mean 74.39 75.19 74.79 kg Median 72.50 73.20 72.50 Caucasian 70 70.7 67 66.3 137 68.5 African-American 17 17.2 23 22.8 40 2 Hispanic 1 3 3.0 4 2.0 Asian 8 8.1 3 3.0 11 5.5 3 3.0 5 5.0 8 4.0 23 23.2 28 27.7 51 25.5 26 26.3 16 15.8 42 2 16 16.2 17 16.8 33 16.5 9 9.1 11 10.9 20 1 3 3.0 3 3.0 6 3.0 0 1 1 22 22.2 25 24.8 47 23.5 Ca 38 38.4 44 43.6 82 4 Ca 33 33.3 36 35.6 69 34.5 Al Ca 10 10.1 9 8.9 19 9.5 Al 6 6.1 2 2.0 8 4.0 Al Ca 4 4.0 4 4.0 8 4.0 P PB-94 3 3.0 1 4 2.0 PB-94+ Ca 2 2.0 2 2.0 4 2.0 PB-94+ Ca 2 2.0 1 3 1.5 PB-94+Al 0 1 1 Ca+ 0 1 1 1 0 1 82 82.8 87 86.1 169 84.5 17 17.2 14 13.9 31 15.5 PTx 88 88.9 97 96.0 185 92.5 11 11.1 4 4.0 15 7.5 Mean 62 54.47 57.86 Median 43.20 35.00 37.10 D 44 44.4 41 4 85 42.5 55 55.6 60 59.4 115 57.5 Ca meq/l 2.5 31 3 29 28.7 60 3 2.5 33 33.3 34 33.7 67 33.5 2.5 35 35.4 38 37.6 73 36.5 * Wilcoxon Fisher p 0.767 0.878 0.782 0.339 57 0.808 61 64 0.237 68 0.920-239

3 202 PB-94 100 102 PB-94 39 28 PB-94 19 5 4 4 2 1 4 12 4 2 4 3 3 4 PB-94 86% 80% PB-94 6.52g/ 4.32g/ 5 1 P Mean P 69 P P PB-94 5.2mg/dL 5.2mg/dL PB-94-2.2mg/dL p<01-2.0mg/dl p<01 Wilcoxon Wilcoxon p=0.483 8.0 Serum Phosphorus P mg/dl (mg/dl) 7.5 7.0 6.5 6.0 5.5 Renagel PB-94 C alcium 5.0 4.5 Screening 0 3 6 9 12 16 20 24 28 32 26 36 40 44 48 52 Study Week 69 P Mean S.E. 2 P P 5.0mg/dL P PB-94 83% 63/76 86% 70/81 P PB-94 54% 41/76 52% 42/81-240

3 Ca Mean Ca 70 Ca PB-94 9.38mg/dL 9.74mg/dL PB-94-16mg/dL p=66 0.466 mg/dl p<01 Wilcoxon Ca Wilcoxon p<01 1 Serum Ca Calcium mg/dl (mg/dl) 1 9.5 9.0 PB-94 Renagel Calcium 8.5 Screening 0 3 6 9 12 16 20 24 28 32 26 36 40 44 48 52 Study Week 70 Ca Mean S.E. 4 Ca Ca 1mg/dL 1 Ca 1mg/dL PB-94 17% 13/76 43% 35/81 Fisher p<01 Ca 1mg/dL PB-94 5% 4/76 16% 13/81 Fisher p=39 Ca 1mg/dL 1 Ca 1mg/dL PB-94 5% 4/76 20% 16/81 Fisher p=07 Ca 1mg/dL PB-94 3% 2/76 4% 3/81 Fisher p=00-241

5 Ca P Mean Ca P 71 Ca P PB-94 48.53 mg/dl 2 50.70 mg/dl 2 PB-94-29 mg/dl 2 p<01-15.64 mg/dl 2 p<01 Wilcoxon Ca P PB-94 Ca P Wilcoxon p=0.104 Serum Calcium Ca P x Phosphorus mg/dl Product 2 (mg 2 /dl 2 ) 75 Renagel PB-94 70 Calcium 65 60 55 50 45 40 Screening 0 3 6 9 12 16 20 24 28 32 26 36 40 44 48 52 Study Week 71 Ca P Mean S.E. 6 intact-pth Median intact-pth 146 washout intact-pth PB-94 135.00pg/mL 138.00pg/mL washout intact-pth PB-94 235.00pg/mL 200pg/mL PB-94 intact-pth 150 300pg/mL 215. 00pg/mL 128.00pg/mL intact-pth intact-pth 146 intact-pth pg/ml n Mean Median Mean p * washout 91 196.81 135.00 PB-94 92 296.22 235.00 75 274.91 215.00-3.34 0.821 washout 95 185.54 138.00 95 273.81 200 81 198.49 128.00-87.91 <01 * Wilcoxon **Wilcoxon p ** 03-242

7 intact-pth 150 300pg/mL intact-pth PB-94 75% 57/76 64% 52/81 Fisher p=0.119 intact-pth PB-94 37% 28/76 25% 20/81 Fisher p=0.117 8 Mean OC ALP 147 OC ALP PB-94 OC PB-94 58.86ng/mL 15.80ng/mL p<01 ALP PB-94 20.39U/L 6.81U/L p<01 Wilcoxon ICTP 147 OC ALP n Mean Median OC ng/ml ALP U/L PB-94 PB-94 74 135.48 90 59 203 138.00 78 124.33 89.75 67 128.40 183.98 75 22.52 19.00 71 43.11 35.90 80 22.91 19.75 78 34 23.10 9 148 PB-94 T-Cho LDL-Cho HDL-Cho TG 148 mg/dl n p * T-Cho LDL-Cho HDL-Cho TG *Wilcoxon PB-94 75 183.1 14 p<01 80 183.7 18 N.S. PB-94 70 103.9 63.9 p<01 76 10 102.7 N.S. PB-94 75 42.8 42.4 N.S. 79 46.4 44.6 N.S. PB-94 75 206.1 182.9 N.S. 80 186.6 166.7 N.S. Mean -243

10 Calcification volume Agatston score 149 Calcification volume Median PB-94 513.75 502.75 PB-94 653.75 379.00 Calcification volume PB-94 Agatston score Median PB-94 682.85 600.40 PB-94 746.40 366.50 Agatston score PB-94 Calcification volume Agatston score 0 149 EBT Calcification volume Agatston score PB-94 PB-94 p * n=92 n=94 n=92 n=94 p * n (%) 75 82 79 84 75 82 79 84 Mean 1201.46 851.74 11 1713 1125.25 13 Median 513.75 502.75 682.85 600.40 n (%) 75 82 73 78 75 82 73 78 Mean 2175.25 1886.52 0.411 3873.88 3232.72 0.391 Median 653.75 379.00 746.40 366.50 n (%) 38 41 28 30 38 41 28 30 Mean 137.21 43.70 0.134 214.40 54.82 0.111 Median 0 0 0 0 n (%) 46 50 40 43 46 50 40 43 Mean 782.77 439.57 0.383 1603.90 769 0.407 Median 4.65 0 4.20 0 n (%) 5 5 2 2 5 5 2 2 Mean 78.19 2.34 0.239 176.52 2.59 0.239 Median 0 0 0 0 n (%) 1 1 0 1 1 0 Mean 8 0 0.317 0.19 0 0.317 Median 0 0 0 0 * Wilcoxon -244

150 Calcification volume MedianPB-94 16.00 38.05 Agatston score MedianPB-94 0 36.55 PB-94 Calcification volume Agatston score Mild/ Moderate PB-94 26 n 22 15 28 25 150 Calcification volume Agatston score PB-94 p * PB-94 p * n 66 75 66 75 Mean 59.17 135.28 76-134.38 110.31 02 Median 8.65 29.40 0 55.70 n 12 13 12 13 None Mean 1.81 2.20 0.418 0.70 4 0.371 Median 0 0 0 0 n 15 23 15 18 Mild Mean 16.35 55 0.106 8.41 49.09 /Moderate Median 10 23.90 8.90 39.05 0.124 n 17 23 10 18 Severe Mean 140.32 149.24 0.826 195.26 159.40 0.866 Median 80.90 99.40 133.15 111.15 n 22 16 29 26 Very Severe Mean 56.95 345.87 39-377.81 173.03 04 Median 6.45 280.70-181.20 195.25 n 62 70 62 70 Mean 158 177.31 0.312-45.72 151.28 39 Median 16.00 38.05 0 36.55 n 12 13 12 13 None Mean 1.49 4.07 0.213 1.56 3.89 0.213 Median 0 0 0 0 n 14 21 14 17 Mild Mean 7.11 72.82 10 3 74.06 /Moderate Median 7.75 38.40 5.85 39.50 27 n 14 21 8 15 Severe Mean 254.99 200.30 0.826 399.85 299.41 00 Median 132.75 215.60 194.30 330.10 Very Severe Mean Median 255.35 210 441.55 669.40 0.300-216.40-33.30 191.54 157.70 0.114 * Wilcoxon -245

151 Calcification volume MedianPB-94 72.45 115.45 Agatston score MedianPB-94 0 75.05 PB-94 Agatston score Third Tirtile PB-94 26 n 16 19 18 21 151 Calcification volume Agatston score PB-94 p * PB-94 p * n 66 75 66 75 Mean 166.55 294.46 0.120-594.72 230.33 29 Median 25.65 77.90 0 10.80 n 14 18 14 18 None Mean 0 13.73 69 0 14 69 Median 0 0 0 0 n 16 24 16 24 First Mean 47.88 65.66 29 47.84 74.80 Tirtile Median 27.20 41.25 32.80 50.35 0.498 n 20 14 18 13 Second Mean 75.60 344.02 21 27.38 236.26 Tirtile Median 95.75 348.85 97.85 373.80 0.155 n 16 19 18 20 Third Mean 544.62 812.92 0.345-2256 610.48 Tirtile Median 404.05 630-2006.10 49.10 13 n 62 70 62 70 Mean 240.93 509.88 0.451-531.99 185.36 10 Median 72.45 115.45 0 75.05 n 13 17 13 17 None Mean 0 1.91 0.126 0 6 0.126 Median 0 0 0 0 n 16 23 16 23 First Mean 77.06 118.70 0.449 75.84 130.85 Tirtile Median 63.00 114.10 42.95 103.80 0.297 n 17 11 15 9 Second Mean 304.73 529.57 0.258 440.79 543.71 Tirtile Median 270.20 453.30 414.80 440 0.765 Third Tirtile * Wilcoxon Mean Median 532.77 620 1426.51 1182.50 71-2267.14-1765 240.20 673.10 21-246

152 30 R-5 Calcification volume Median PB-94 9.68% 28.45% Agatston score Median PB-94 5.77% 25.38%PB-94 Calcification volume PB-94 21.98% 37.10% PB-94 Agatston score PB-94 4.60% 28.36%PB-94 26 152 % Calcification volume Agatston score PB-94 p * PB-94 p * n 51 58 51 59 Mean Median 11.81 8.92 24.16 17.72 19 4.71 9 22.37 14.33 n 49 52 48 51 Mean Median 17.81 9.95 34.97 23.32 24 6.79 2 27.71 23.73 n 47 53 47 54 Mean Median Mean Median * Wilcoxon 29 9.68 36.44 28.45 44 14.56 5.77 37.71 25.38 n 46 48 45 47 36.81 21.98 57.55 37.10 50 23.09 4.60 52 28.36 12 10 17 16 Calcification volume Agatston score 0-247

6 1 PB-94 62 62.6% 217 65 64.4% 199 PB-94 37.4% 55.4% p=11 Fisher PB-94 29.3% 47.5% p=09 Fisher PB-94 22.2% 38.6% p=14 Fisher PB-94 NOS 22 22.2% 33 NOS 23 22.8% 32 PB-94 16.2% 6.9% p=47 Fisher PB-94 4.0% 17.8% p=02 Fisher 153 PB-94 37 37.4% 76 17 16.8% 27 153 MedDRA SOC PB-94 n=99 n=101 % % p * 37 37.4 76 17 16.8 27 01 3 3.0 4 1 1 0.366 2 2.0 2 1 1 19 2 2.0 2 2 2.0 2 00 1 1 1 1 00 1 1 0 0 0.495 1 1 5 5.0 5 0.211 1 1 0 0 0.495 *Fisher -248

2 PB-94 41 58 possibly related PB-94 1 PB-94 S 250mm 20mm S PB-94 6 5 3 Cl PB-94 3.61mEq/L -0.47mEq/L p<01 Wilcoxon CO 2 PB-94 0.72mEq/L 3.57mEq/L p<01 Wilcoxon UA PB-94-0.91mg/L -0.26mg/L p=01 Wilcoxon TIBC PB-94 1.17mcg/dL -22.69mcg/dL p=07 Wilcoxon ALP PB-94 28.69U/L 4.10U/L p<01 Wilcoxon -249

7 EBT Agatston score Calcification volume Agatston score MedianPB-94 0 36.55 PB-94 p=39 Agatston score Median PB-94 0 75.05 PB-94 p=10 Calcification volume PB-94 P Ca Ca Ca P PB-94 Ca intact-pth PB-94 intact-pth 150~300pg/mL intact-pth Ca P LDL-Cho R-7-250

. 6 6 1 24 48 44 154 154 1 1 2 2 1 2 3 P Ca P Ca 4 5 1. 1 8 16 18 20 29 2 1R-8, 9 4.2% 2000 5.5% 1999-251

61.2 2000 60.2 1996 3 4 2 QOL 155 155 R-10 R-11 mg/ mg/ mg/ mg/ kcal/kg/ g/kg/ ml/ 700 600 150/kg 1500 30 35 1.2 15/kg 600 1200 1000 1500 1000 Na 1600 2700 35 1 1000 1500 b 156 156 n=51 b n=129 mg/ mg/ mg/ mg/ kcal/ g/ g/ 814 214 356 144 2885 1024 2104 580 1813 355 65 15 56 14 786 315 432 237 2136 1113 1508 1120 1413 636 60 24 56 29 Mean S.D. 3 R-12, 13 2000 744 13,290-252

2. 1 157 157 P P 250mg 440mg 403mg P 4.0 P 6mg/dL 8 2 1 4 1 3 P 2.5 P 5.5mg/dL 1 2 4 4 1 3 48 44 157 192 2 158 Ca D P P 158 % n=157n=192 96 61.1 120 62.5 61 38.9 72 37.5 55.1 10.4 56.1 14.6 kg 56.1 9.9 8 23.7 112 7 15 9.6 0 30 19.1 27 14.1 57 29.7 65 33.9 43 22.4 9.9 6.7 3.8 3.7 D Ca Ca Al Ca AlCa PB-94 135 86.0 83 52.9 89 56.7 85 54.1 54 34.4 145 92.4 4 2.5 0 0 0 8 5.1 181 94.3 143 74.5 92 47.9 70 36.5 55 28.6 24 12.5 1 36 18.8 3 101 52.6 27 14.1 Ca Mean S.D. -253

3 P Ca Mean S.D. P washout washout PB-94 n=61 192 washout 7.83 7mg/dL P 48 5.44 0.91mg/dL -2.28 1.55mg/dL 8.66 2.21mg/dL 6.43 1.94mg/dL -2.22 2.40mg/dL Ca washout 9.04 0.70mg/dL 48 9.09 8mg/dL 4 8mg/dL 9.09 0.77mg/dL 9.41 0.80mg/dL 0.32 0.88mg/dL P Ca 4 159 159 g/ n Mean Min Max 157 4.46 0.18 9.00 192 5.02 0.39 11.22 5 ICH Medical Dictionary for Regulatory ActivitiesMedDRA Ver. 2.2 1 72 160 100% 157/157 97.4% 187/192 86.6% 84.1% 54.1% 73.4% -254

70.8% 62.0% 26.1% 24.8% 24.8% 22.3% NOS 17.2% 35.4% NOS 33.3% NOS 25.0% 17.7% 160 % MedDRA SOC MedDRA SOC 5.7 10.9 41.4 4 18.5 36.5 19.1 33.9 0 / 54.1 54.2 5.1 5.7 6.3 3.2 4.2 3 53.1 22.3 12.0 1.9 13.0 86.6 73.4 5.7 9.9 35.7 70.8 4.7 2.5 21.7 62.0 0 2.6 3 39.1 84.1 58.9 9.6 34.4 23.6 21.9 8.9 44.8-255

161 72.0% 113/157 25.5% 49/192 66.9% 20.3% 10.8% 2.1% R-14 R-15 26.1% NOS 4 20.4% 19.7% 15.9% 9.6% 5.7% 7.3% 5.7% NOS 4.2% 1 250g 1 8 9g 45%R-16 R-17 S 40% R-18 59% R-1971% R-20 34.4% 43.3% 28.6% 72 8 55 7 2 1 NOS NOS 32 16 9 1 7 1 1-256

2 1 1 2 1 32 9 20 3 25 19 5 2 3 25 10 11 1 2 1 Cu Zn 2 3 ALP 5 MedDRA SOC 161 % MedDRA SOC 0 3.8 4.7 0 0 0 0 0 0 66.9 20.3 2.1 0 0 0 10.8 2.1-257

2 % NOS 16 8.3% 2 NOS 2 2 2 NOS 1 1 1 NOS 1 NOS NOS NOS 1 NOS NOS NOS 1 1 1 Not related 9.2% 2000 23.1% 1996 2 73 1 8 2 53.5% 9 48 6.4 16.6% 3 162 T-Cho LDL-Cho HDL-Cho ALP Cl 3. P Ca -258

-259

% 100 90 n=157 80 70 60 50 40 30 20 10 0 n=192 % 0 10 20 30 40 50 60 70 80 90 100 18.5 5.7 2.5 6.4 3.8 3.8 NOS NOS NOS NOS NOS NOS NOS NOS NOS NOS NOS NOS NOS NOS NOS 10.9 6.8 2.1 5.2 2.6 2.1 4.2 6.3 5.2 4.7 4.2 2.6 2.6 2.6 2.1 2.1 36.5 72-260

% 100 90 n=157 80 70 60 50 40 30 20 10 0 n=192 % 0 10 20 30 40 50 60 70 80 90 100 22.3 5.1 3.8 1.9 3.2 2.5 7.0 3.2 3.2 3.2 3.2 1.9 NOS NOS NOS / NEC NOS NOS NOS NEC NEC NOS NEC NOS 5.7 72 3.1 2.6 2.1 4.2 12.0-261

% 100 90 n=157 80 70 60 50 40 30 20 10 0 n=192 % 0 10 20 30 40 50 60 70 80 90 100 86.6 26.1 24.8 24.8 22.3 66.9 26.1 19.7 17.2 15.9 17.2 3.8 16.6 9.6 14.6 5.1 11.5 5.7 9.6 5.7 6.4 5.7 5.7 1.9 3.2 2.5 1.9 5.1 4.5 1.9 1.9 1.9 1.9 1.9 NEC NOS NOS NOS NOS NOS NOS 3.1 4.7 4.7 2.1 5.7 10.9 2.6 2.6 15.6 3.6 7.3 4.2 7.3 17.7 25.0 35.4 33.3 20.3 73.4 72-262

% 100 90 n=157 80 70 60 50 40 30 20 10 0 n=192 % 0 10 20 30 40 50 60 70 80 90 100 35.7 12.1 8.3 5.1 4.5 2.5 2.5 1.9 1.9 NOS NOS NOS NOS NOS NOS NOS NOS NOS NOS 3.1 3.6 3.1 2.1 6.3 4.7 8.9 23.4 10.4 4.7 2.6 17.2 70.8 72-263

% 100 90 n=157 80 70 60 50 40 30 20 10 0 n=192 % 0 10 20 30 40 50 60 70 80 90 100 84.1 77.1 3.8 2.5 1.9 NOS NOS NOS NOS NOS NOS NOS NOS NOS NOS NOS NOS NOS NOS NOS 6.8 7.3 6.3 5.7 4.2 3.1 2.6 2.6 2.6 2.6 2.6 9.9 8.3 21.9 17.2 58.9 72-264

% 100 90 n=157 80 70 60 50 40 30 20 10 0 n=192 % 0 10 20 30 40 50 60 70 80 90 100 3.8 2.5 2.5 2.5 NOS NOS NOS NOS NOS NOS NOS NOS NOS NOS NOS NOS NOS NOS NOS NOS NOS NOS NOS NOS NOS NOS NOS NOS NOS NOS NOS NOS NOS NOS 2.6 72 6.3 4.2 4.2 5.2 3.6 3.1 12.5 2.1 5.2-265

% 100 90 n=157 80 70 60 50 40 30 20 10 0 n=192 % 0 10 20 30 40 50 60 70 80 90 100 23.6 3.8 3.2 2.5 1.9 1.9 NOS NEC NOS NOS NOS NOS NOS NOS NOS NOS NOS NOS NOS NOS NOS NOS 3.1 72 3.1 21.9-266

% 100 90 n=157 80 70 60 50 40 30 20 10 0 n=192 % 0 10 20 30 40 50 60 70 80 90 100 41.4 10.8 10.2 5.1 3.8 3.2 2.5 1.9 1.9 3.2 1.9 3.8 1.9 2.5 2.5 2.5 2.5 1.9 1.9 1.9 1.9 1.9 NOS NOS 2 NOS NOS NOS ph NOS B 12 PO 2 2.6 2.1 2.1 3.6 6.8 8.3 2.1 4 72-267

% 100 90 n=157 80 70 60 50 40 30 20 10 0 n=192 % 0 10 20 30 40 50 60 70 80 90 100 ph C- PO 2 X NOS NOS NOS NOS - NOS INR NOS 5.2 4.2 72 2.1 7.3 5.2 2.1-268

% 100 90 n=157 80 70 60 50 40 30 20 10 0 n=192 % 0 10 20 30 40 50 60 70 80 90 100 54.1 19.1 22.3 3.8 6.4 1.9 14.6 12.7 1.9 4.5 2.5 9.6 6.4 3.8 1.9 NOS NOS NOS NOS NOS NOS NOS NOS 2.6 3.6 2.1 2.1 2.1 2.1 2.6 2.6 3.1 3.6 3.1 8.9 7.3 5.7 19.3 10.4 21.9 24.0 4.7 33.9 54.2 72-269

% 100 90 n=157 80 70 60 50 40 30 20 10 0 n=192 % 0 10 20 30 40 50 60 70 80 90 100 3 12.7 3.8 3.2 2.5 1.9 1.9 NOS NOS NOS NOS NOS NOS ( ) NOS NOS NOS NOS NOS NOS NOS NEC NEC NEC NOS 2.1 2.1 72 2.6 5.7 9.4 6.3 2.6 21.9 28.6 53.1-270

% 100 90 n=157 80 70 60 50 40 30 20 10 0 n=192 % 0 10 20 30 40 50 60 70 80 90 100 5.7 1.9 1.9 1.9 NOS NOS NEC NOS NOS NEC NOS NOS NOS NEC NEC NEC NOS NOS NOS NOS 2.1 3.1 2.1 72 2.6 9.9 3.1 2.1 13.0-271

% 100 90 n=157 80 70 60 50 40 30 20 10 0 n=192 % 0 10 20 30 40 50 60 70 80 90 100 21.7 3.8 8.3 3.8 1.9 NOS NOS NOS NOS NOS NOS NOS NOS NOS NOS NOS NOS 3.1 2.6 72 4.7 4.7 3.6 2.6 2.1 2.1 2.1 4.7 12.0 8.9 8.3 7.3 2.6 3.1 9.4 19.8 26.6 2.1 62.0-272

% 100 90 n=157 80 70 60 50 40 30 20 10 0 n=192 % 0 10 20 30 40 50 60 70 80 90 100 3 14.6 4.5 3.8 1.9 1.9 NOS NOS NOS NEC NOS NOS NOS NOS NOS NOS 4.7 3.6 2.1 72 2.1 3.6 3.1 10.4 4.2 39.1-273

% 100 90 n=157 80 70 60 50 40 30 20 10 0 n=192 % 0 10 20 30 40 50 60 70 80 90 100 9.6 8.3 8.9 1.9 NOS NOS NOS NOS NOS NOS NOS NOS NOS NOS NOS 4.7 2.1 2.1 2.1 6.3 3.6 4.2 26.0 20.3 12.5 34.4 44.8 72-274

% 100 90 n=157 80 70 60 50 40 30 20 10 0 n=192 % 0 10 20 30 40 50 60 70 80 90 100 NOS NOS NOS NOS NOS NOS NOS 72-275

-276 73 n=157 3.6 3.5 2.6 3.3 4.7 6.1 5.9 8.3 1 46.5 8.2 5.5 9.7 8.8 9.5 12.3 6.3 6.8 6.7 9.7 6.0 11.5 3.6 5.5 4.4 5.3 5.2 13.9 3.1 1 8.1 17.2 26.0 2 1 6.4 1 1 9.5 14.8 1 15.2 14.8 16.6 2 53.5 0 10 20 30 40 50 60 70 80 90 100 % 1 4W 5 8W 9 12W 13 16W 17 20W 21 24W 25 28W 29 32W 33 36W 37 40W 41 44W 45 48W 1 4W 5 8W 9 12W 13 16W 17 20W 21 24W 25 28W 29 32W 33 36W 37 40W 41 44W 45 48W 1 4W 5 8W 9 12W 13 16W 17 20W 21 24W 25 28W 29 32W 33 36W 37 40W 41 44W 45 48W n=192 7.8 3.8 3.9 1.7 4.2 1.9 2.0 2.8 0.7 3.0 0.8 0.7 22.4 21.1 15.6 12.8 16.1 12.7 18.0 17.2 12.7 14.1 11.8 9.9 9.0 11.5 8.1 12.8 9.3 8.9 7.6 10.7 1 8.1 8.7 8.1 8.9 1 8.3 10.8 8.0 7.6 9.9 5.9 9.4 0 10 20 30 40 50 60 70 80 90 100 %

-277 73 1 4W 5 8W 9 12W 13 16W 17 20W 21 24W 25 28W 29 32W 33 36W 37 40W 41 44W 45 48W 1 4W 5 8W 9 12W 13 16W 17 20W 21 24W 25 28W 29 32W 33 36W 37 40W 41 44W 45 48W 1 4W 5 8W 9 12W 13 16W 17 20W 21 24W 25 28W 29 32W 33 36W 37 40W 41 44W 45 48W n=192 0.7 1.4 0.7 0.7 1.2 1.1 1.1 0.7 0.7 0.7 6.3 2.2 4.9 1 4.0 3.8 4.2 1.2 3.9 4.3 5.7 9.4 6.7 5.6 9.0 4.7 5.7 6.0 5.8 7.2 5.9 7.3 16.5 7.4 17.6 17.2 14.7 21.5 13.7 16.9 18.3 10.8 16.7 0 10 20 30 40 50 60 70 80 90 100 % n=157 2.7 1.9 4.0 1.4 1.5 1.5 0.8 0.9 0.9 1.8 0.9 0.9 2.5 0.8 3.7 5.3 3.8 6.4 6.4 4.7 7.6 3.7 3.0 3.1 4.9 3.4 7.9 2.7 1.8 6.4 5.7 1 6.9 5.2 3.8 7.1 3.3 5.2 6.1 0.9 2.7 2.6 0 10 20 30 40 50 60 70 80 90 100 %

-278 73 45 48W 1 4W 5 8W 9 12W 13 16W 17 20W 21 24W 25 28W 29 32W 33 36W 37 40W 41 44W 1 4W 5 8W 9 12W 13 16W 17 20W 21 24W 25 28W 29 32W 33 36W 37 40W 41 44W 45 48W 1 4W 5 8W 9 12W 13 16W 17 20W 21 24W 25 28W 29 32W 33 36W 37 40W 41 44W 45 48W n=192 1.5 0.7 1.5 2.1 5.5 2.0 4.4 1.2 3.5 4.4 2.2 2.1 13.4 9.6 13.4 15.9 10.7 10.1 1 16.9 11.1 9.2 12.5 10.2 3.0 5.6 4.1 6.0 5.7 6.0 4.4 5.4 4.7 4.7 0 10 20 30 40 50 60 70 80 90 100 % n=157 0.7 3.2 4.0 2.8 4.4 4.8 2.7 2.5 4.4 5.3 2.4 3.4 1.8 0.9 4.5 5.3 3.9 4.9 2.6 3.5 1.8 1 0.9 3.2 0.7 1.4 0.7 1.5 5.5 4.9 3.4 1.8 1.8 1.8 2.7 0 10 20 30 40 50 60 70 80 90 100 %

-279 73 1 4W 5 8W 9 12W 13 16W 17 20W 21 24W 25 28W 29 32W 33 36W 37 40W 41 44W 45 48W 1 4W 5 8W 9 12W 13 16W 17 20W 21 24W 25 28W 29 32W 33 36W 37 40W 41 44W 45 48W 1 4W 5 8W 9 12W 13 16W 17 20W 21 24W 25 28W 29 32W 33 36W 37 40W 41 44W 45 48W n=157 2.5 2.7 2.8 2.2 3.8 2.5 3.4 2.2 3.8 3.9 2.5 0.7 4.1 3.0 2.3 6.3 4.1 0.9 2.6 3.5 1.8 4.5 2.5 0.9 1.8 3.5 0.9 0.9 2.5 6.9 3.5 4.4 2.7 3.6 0 10 20 30 40 50 60 70 80 90 100 % n=192 0.8 1.5 0.7 0.7 4.0 1.9 2.4 1.7 1.1 9.4 5.9 1 1 12.0 8.2 6.5 6.5 12.8 11.1 6.3 7.1 3.0 3.5 4.8 5.3 7.0 3.6 5.8 7.8 4.9 4.7 0 10 20 30 40 50 60 70 80 90 100 %

-280 73 n=157 0.9 1.8 1.8 0.9 0.9 0.9 0.8 0.7 1.8 1.8 0.9 0.8 0.7 0.7 1.5 2.0 0.8 1.5 1.5 0.7 1.9 0 10 20 30 40 50 60 70 80 90 100 % n=192 7.8 4.9 3.9 4.1 3.0 4.4 3.3 6.2 2.1 3.0 4.7 2.7 2.1 2.2 0.8 1.1 1.1 1.2 1.4 0.7 1.5 3.9 0 10 20 30 40 50 60 70 80 90 100 % 1 4W 5 8W 9 12W 13 16W 17 20W 21 24W 25 28W 29 32W 33 36W 37 40W 41 44W 45 48W 1 4W 5 8W 9 12W 13 16W 17 20W 21 24W 25 28W 29 32W 33 36W 37 40W 41 44W 45 48W 1 4W 5 8W 9 12W 13 16W 17 20W 21 24W 25 28W 29 32W 33 36W 37 40W 41 44W 45 48W

-281 73 1 4W 5 8W 9 12W 13 16W 17 20W 21 24W 25 28W 29 32W 33 36W 37 40W 41 44W 45 48W 1 4W 5 8W 9 12W 13 16W 17 20W 21 24W 25 28W 29 32W 33 36W 37 40W 41 44W 45 48W 1 4W 5 8W 9 12W 13 16W 17 20W 21 24W 25 28W 29 32W 33 36W 37 40W 41 44W 45 48W n=157 0.9 0.8 0.9 0.9 1.8 1.7 0.8 1.5 0.7 0.7 0.7 0.7 0 10 20 30 40 50 60 70 80 90 100 % n=192 0.8 1.1 0.7 0.7 0.7 0.7 1.7 1.8 0 10 20 30 40 50 60 70 80 90 100 %

-282 73 1 4W 5 8W 9 12W 13 16W 17 20W 21 24W 25 28W 29 32W 33 36W 37 40W 41 44W 45 48W 1 4W 5 8W 9 12W 13 16W 17 20W 21 24W 25 28W 29 32W 33 36W 37 40W 41 44W 45 48W 1 4W 5 8W 9 12W 13 16W 17 20W 21 24W 25 28W 29 32W 33 36W 37 40W 41 44W 45 48W n=157 1.7 0 10 20 30 40 50 60 70 80 90 100 % n=192 0.8 1.9 0.7 0.8 2.2 2.1 2.8 2.4 1.7 3.3 0 10 20 30 40 50 60 70 80 90 100 %

-283 73 1 4W 5 8W 9 12W 13 16W 17 20W 21 24W 25 28W 29 32W 33 36W 37 40W 41 44W 45 48W 1 4W 5 8W 9 12W 13 16W 17 20W 21 24W 25 28W 29 32W 33 36W 37 40W 41 44W 45 48W 1 4W 5 8W 9 12W 13 16W 17 20W 21 24W 25 28W 29 32W 33 36W 37 40W 41 44W 45 48W ( n=157 0.7 2.7 3.4 1.5 0.7 0.7 0.8 0.8 0 10 20 30 40 50 60 70 80 90 100 % n=192 1.4 5.3 6.3 6.5 3.5 6.1 7.0 10.9 0.8 1.9 1.7 0.7 8.3 7.0 5.9 7.1 2.1 1.1 1.8 0.7 0 10 20 30 40 50 60 70 80 90 100 %

162 157 n t t p 192 n t t p mmhg 156 149.5 ± 18.7 149.5 ± 21.7 ± 17.9 <01 00 mmhg 156 8 ± 12.3 80.1 ± 12.4-0.9 ± 11.8-0.899 0.370 kg 157 58.70 ± 10.14 58.11 ± 10.23-0 ± 1.52-4.922 <01 kg 157 56.10 ± 9.92 55.67 ± 13-0.43 ± 1.41-3.776 <01 RBC 10 4 /µl 157 318.5 ± 38.9 315.5 ± 37.3-3.0 ± 39.6-0.938 0.349 192 356.0 ± 47.3 348.9 ± 49.2-7.1 ± 52.4-1.888 61 MCV fl 184 91.93 ± 6.71 92.76 ± 7.48 0.83 ± 4.60 2.437 16 MCH pg 184 30.49 ± 2.56 30.39 ± 2.82-0.10 ± 1.70-0.762 0.447 MCHC % 184 33.14 ± 1 32.73 ± 5-0.41 ± 9-5.074 <01 Hb g/dl 157 9.98 ± 0.98 9.87 ± 7-0.10 ± 1.28-24 0.307 192 10.78 ± 1.26 13 ± 2-0.25 ± 1.50-2.289 23 Ht % 157 30.74 ± 3.00 33 ± 3.19-0.11 ± 3.79-0.371 0.711 192 32.53 ± 3.76 32.19 ± 4.07-0.34 ± 4.62-16 0.311 Pt 10 4 /µl 157 19.29 ± 7.03 18.94 ± 7.54-0.35 ± 3.68-1.176 0.241 192 22.11 ± 6.99 20.38 ± 6.85-1.73 ± 5.05-4.752 <01 WBC /µl 157 5662.2 ± 1596.2 5435.3 ± 1713.6-226.9 ± 1228.5-2.314 21 192 7456.8 ± 2664.6 7173.4 ± 2602.4-283.3 ± 1921.4-2.043 42 Neu % 190 60.90 ± 12.48 62.24 ± 12.61 5 ± 12.39 1.497 0.136 Lympho % 190 25.09 ± 10.39 23.55 ± 9.31-1.55 ± 9.66-2.209 28 Mono % 190 6.94 ± 2.76 7.33 ± 2.94 0.39 ± 3.24 60 98 Eosino % 190 6.13 ± 4.22 6.11 ± 6.92-2 ± 5.38-50 0.960 Baso % 190 9 ± 2 3 ± 7-7 ± 0.74-1.215 0.226 P mg/dl 157 6.75 ± 7 5.78 ± 1.17-0.97 ± 1.85-6.586 <01 192 8.66 ± 2.21 6.43 ± 1.94-2.22 ± 2.40-12.864 <01 Ca mg/dl 157 9.63 ± 0.96 9.37 ± 0.87-0.27 ± 0.81-4.084 <01 Ca mg/dl 192 9.09 ± 0.77 9.41 ± 0.80 0.32 ± 0.88 5.100 <01 Ca P mg/dl 2 157 64.68 ± 15.71 54.27 ± 12.83-10.40 ± 16.86-7.732 <01 192 78.35 ± 19.94 60.28 ± 18.00-18.08 ± 22.16-105 <01 Alb g/dl 157 3.88 ± 0.27 3.92 ± 0.28 4 ± 0.24 1.993 48 192 3.81 ± 0.26 3.78 ± 0.33-3 ± 0.24-1.447 0.149 TP g/dl 157 6.58 ± 0.46 6.46 ± 0.48-0.12 ± 0.38-4.012 <01 192 7.13 ± 6 7.08 ± 9-5 ± 0.47-1.484 0.139 g/dl 192 3.32 ± 7 3.30 ± 7-3 ± 0.39-0.898 0.370 AST IU/L 157 12.0 ± 7.0 12.2 ± 5.9 0.2 ± 6.6 0.397 92 192 14.3 ± 8.9 14.6 ± 9.1 0.2 ± 8.6 0.368 0.713 ALT IU/L 157 1 ± 8.8 1 ± 7.0-0.7 ± 7.1-1.284 0.201 192 13.2 ± 9.6 14.2 ± 22.0 ± 23.2 01 49 LDH IU/L 157 306.5 ± 72.0 292.0 ± 75.9-14.5 ± 67.7-2.688 07 192 17 ± 38.5 169.0 ± 48.3 - ± 45.4-0.474 36 ALP IU/L 157 167.2 ± 67.5 212.6 ± 86.3 45.3 ± 7 7.934 <01 190 93.1 ± 64.8 125.4 ± 105.0 32.3 ± 72.6 6.133 <01 T-Cho mg/dl 157 159.5 ± 34.0 133.3 ± 29.7-26.2 ± 22.0-14.911 <01 192 175.3 ± 44.6 147.4 ± 38.2-27.9 ± 35.4-10.897 <01 HDL-Cho mg/dl 157 43.2 ± 14.2 48.0 ± 14.4 4.9 ± 8.6 7.092 <01 190 36.4 ± 13.7 42.3 ± 13.6 5.9 ± 11.2 7.239 <01 LDL-Cho mg/dl 157 90.9 ± 27.2 67.2 ± 23.0-23.7 ± 18.5-16.036 <01 190 106.6 ± 33.8 75.0 ± 29.9-31.5 ± 28.8-15.075 <01 TG mg/dl 157 120.8 ± 78.7 106.7 ± 53.5-14.1 ± 55.8-3.176 01 192 164.4 ± 123.5 151.9 ± 104.2-12.4 ± 104.4-50 0.100 T-Bil mg/dl 157 0.22 ± 8 0.23 ± 9 1 ± 8 1.561 0.120 184 3 ± 0.18 4 ± 0.20 1 ± 0.17 0.886 0.377 BUN mg/dl 157 74.5 ± 13.6 69.9 ± 13.2-4.6 ± 13.1-4.422 <01 192 73.6 ± 18.9 66.9 ± 21.1-6.7 ± 20.9-4.416 <01 BUN mg/dl 157 25.2 ± 7.0 24.5 ± 7.3-0.7 ± 5.5-02 0.111 Cr mg/dl 157 12.96 ± 2.04 12.83 ± 2.29-0.14 ± 1.20-1.443 0.150 192 11.91 ± 3.41 14 ± 3.27-8 ± 2.32-3.447 01 UA mg/dl 157 8.19 ± 1.25 7.61 ± 1.29-8 ± 4-7.005 <01 192 7.11 ± 0 6.32 ± 1.45-0.79 ± 1.28-8.607 <01 Na meq/l 157 139.1 ± 2.8 138.8 ± 3.0-0.3 ± 2.8-11 0.191 192 139.3 ± 3.1 138.7 ± 3.3 - ± 3.4-2.259 25 K meq/l 157 5.16 ± 6 5.20 ± 5 4 ± 1 0.762 0.447 192 4.87 ± 0.70 4.97 ± 5 0.10 ± 0.84 95 92 Cl meq/l 157 101.2 ± 3.0 103.5 ± 3.7 2.3 ± 3.4 8.593 <01 192 99.5 ± 4.2 100.8 ± 4.3 ± 4.2 4.231 <01 Mg mg/dl 157 2.85 ± 0.40 2.86 ± 0.40 1 ± 0.30 14 40 184 2.51 ± 0.45 2.61 ± 0.49 0.10 ± 0.36 3.738 <01 ph 157 7.3543 ± 339 7.3417 ± 418-126 ± 373-4.232 <01 HCO 3 meq/l 157 19.17 ± 2.46 18.08 ± 2.44-9 ± 2.43-5.634 <01 192 17.05 ± 3.82 18.35 ± 4.18 0 ± 4.77 3.767 <01 Mean S.D. -284