14-6.04

Shifts of Laboratory Values During Treatment, Categorized Based on Threshold Ranges, by Visit

Made 2026-10-17 from uploaded data.

CDISCPILOT01

Table 14-6.04

Shifts of Laboratory Values During Treatment, Categorized Based on Threshold Ranges, by Visit

Safety Analysis Set

	Placebo (N=86)		Xan. Low (N=84)		Xan. High (N=84)
	Normal at Baseline	High at Baseline	Normal at Baseline	High at Baseline	Normal at Baseline	High at Baseline
Chemistry
Sodium (mmol/L)
Baseline
n	86	0	82	0	83	0
Normal	86(100%)	0(-%)	82(100%)	0(-%)	83(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 2
n	84	0	78	0	76	0
Normal	84(100%)	0(-%)	78(100%)	0(-%)	76(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 4
n	82	0	70	0	71	0
Normal	82(100%)	0(-%)	70(100%)	0(-%)	71(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 6
n	75	0	62	0	66	0
Normal	75(100%)	0(-%)	62(100%)	0(-%)	66(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 8
n	73	0	58	0	56	0
Normal	73(100%)	0(-%)	58(100%)	0(-%)	56(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 12
n	67	0	50	0	49	0
Normal	67(100%)	0(-%)	50(100%)	0(-%)	49(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 16
n	68	0	40	0	37	0
Normal	68(100%)	0(-%)	40(100%)	0(-%)	37(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 20
n	65	0	30	0	31	0
Normal	65(100%)	0(-%)	30(100%)	0(-%)	31(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 24
n	57	0	26	0	30	0
Normal	57(100%)	0(-%)	26(100%)	0(-%)	30(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 26
n	57	0	24	0	27	0
Normal	57(100%)	0(-%)	24(100%)	0(-%)	27(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
End of Treatment
n	84	0	80	0	79	0
Normal	84(100%)	0(-%)	80(100%)	0(-%)	79(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Potassium (mmol/L)
Baseline
n	86	0	81	0	82	0
Normal	86(100%)	0(-%)	81(100%)	0(-%)	82(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 2
n	84	0	78	0	76	0
Normal	84(100%)	0(-%)	78(100%)	0(-%)	76(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 4
n	82	0	68	0	71	0
Normal	82(100%)	0(-%)	68(100%)	0(-%)	71(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 6
n	75	0	62	0	66	0
Normal	75(100%)	0(-%)	62(100%)	0(-%)	66(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 8
n	73	0	58	0	56	0
Normal	73(100%)	0(-%)	58(100%)	0(-%)	56(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 12
n	67	0	50	0	49	0
Normal	67(100%)	0(-%)	50(100%)	0(-%)	49(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 16
n	68	0	40	0	37	0
Normal	68(100%)	0(-%)	40(100%)	0(-%)	37(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 20
n	64	0	30	0	31	0
Normal	64(100%)	0(-%)	30(100%)	0(-%)	31(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 24
n	56	0	26	0	30	0
Normal	56(100%)	0(-%)	26(100%)	0(-%)	30(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 26
n	57	0	24	0	27	0
Normal	57(100%)	0(-%)	24(100%)	0(-%)	27(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
End of Treatment
n	84	0	79	0	79	0
Normal	84(100%)	0(-%)	79(100%)	0(-%)	79(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Chloride (mmol/L)
Baseline
n	86	0	82	0	83	0
Normal	86(100%)	0(-%)	82(100%)	0(-%)	83(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 2
n	84	0	78	0	76	0
Normal	84(100%)	0(-%)	78(100%)	0(-%)	76(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 4
n	82	0	70	0	71	0
Normal	82(100%)	0(-%)	70(100%)	0(-%)	71(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 6
n	75	0	62	0	66	0
Normal	75(100%)	0(-%)	62(100%)	0(-%)	66(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 8
n	73	0	58	0	56	0
Normal	73(100%)	0(-%)	58(100%)	0(-%)	56(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 12
n	67	0	50	0	49	0
Normal	67(100%)	0(-%)	50(100%)	0(-%)	49(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 16
n	68	0	40	0	37	0
Normal	68(100%)	0(-%)	40(100%)	0(-%)	37(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 20
n	65	0	30	0	31	0
Normal	65(100%)	0(-%)	30(100%)	0(-%)	31(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 24
n	57	0	26	0	30	0
Normal	57(100%)	0(-%)	26(100%)	0(-%)	30(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 26
n	57	0	24	0	27	0
Normal	57(100%)	0(-%)	24(100%)	0(-%)	27(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
End of Treatment
n	84	0	80	0	79	0
Normal	84(100%)	0(-%)	80(100%)	0(-%)	79(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Bilirubin (umol/L)
Baseline
n	86	0	82	0	83	1
Normal	86(100%)	0(-%)	82(100%)	0(-%)	83(100%)	0(0%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	1(100%)
Week 2
n	83	0	78	0	77	1
Normal	82(99%)	0(-%)	77(99%)	0(-%)	77(100%)	1(100%)
High	1(1%)	0(-%)	0(0%)	0(-%)	0(0%)	0(0%)
Week 4
n	79	0	70	0	71	1
Normal	78(99%)	0(-%)	69(99%)	0(-%)	71(100%)	0(0%)
High	1(1%)	0(-%)	0(0%)	0(-%)	0(0%)	1(100%)
Week 6
n	73	0	60	0	65	1
Normal	73(100%)	0(-%)	60(100%)	0(-%)	65(100%)	1(100%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(0%)
Week 8
n	72	0	58	0	55	1
Normal	72(100%)	0(-%)	58(100%)	0(-%)	55(100%)	1(100%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(0%)
Week 12
n	67	0	50	0	49	1
Normal	67(100%)	0(-%)	50(100%)	0(-%)	48(98%)	1(100%)
High	0(0%)	0(-%)	0(0%)	0(-%)	1(2%)	0(0%)
Week 16
n	68	0	40	0	36	1
Normal	68(100%)	0(-%)	40(100%)	0(-%)	36(100%)	1(100%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(0%)
Week 20
n	65	0	29	0	30	1
Normal	65(100%)	0(-%)	29(100%)	0(-%)	29(97%)	1(100%)
High	0(0%)	0(-%)	0(0%)	0(-%)	1(3%)	0(0%)
Week 24
n	57	0	25	0	29	1
Normal	55(96%)	0(-%)	24(96%)	0(-%)	29(100%)	1(100%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(0%)
Week 26
n	57	0	24	0	26	1
Normal	57(100%)	0(-%)	23(96%)	0(-%)	26(100%)	1(100%)
High	0(0%)	0(-%)	1(4%)	0(-%)	0(0%)	0(0%)
End of Treatment
n	84	0	80	0	79	1
Normal	81(96%)	0(-%)	78(98%)	0(-%)	79(100%)	1(100%)
High	1(1%)	0(-%)	0(0%)	0(-%)	0(0%)	0(0%)
Alkaline Phosphatase (U/L)
Baseline
n	84	2	81	0	82	1
Normal	84(100%)	0(0%)	81(100%)	0(-%)	82(100%)	0(0%)
High	0(0%)	2(100%)	0(0%)	0(-%)	0(0%)	1(100%)
Week 2
n	82	2	78	0	77	1
Normal	82(100%)	0(0%)	78(100%)	0(-%)	77(100%)	0(0%)
High	0(0%)	2(100%)	0(0%)	0(-%)	0(0%)	1(100%)
Week 4
n	80	2	69	0	71	1
Normal	80(100%)	0(0%)	69(100%)	0(-%)	71(100%)	0(0%)
High	0(0%)	2(100%)	0(0%)	0(-%)	0(0%)	1(100%)
Week 6
n	75	0	62	0	66	1
Normal	75(100%)	0(-%)	62(100%)	0(-%)	66(100%)	0(0%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	1(100%)
Week 8
n	72	1	58	0	55	1
Normal	72(100%)	0(0%)	57(98%)	0(-%)	55(100%)	0(0%)
High	0(0%)	1(100%)	1(2%)	0(-%)	0(0%)	1(100%)
Week 12
n	66	1	50	0	49	1
Normal	66(100%)	0(0%)	50(100%)	0(-%)	49(100%)	0(0%)
High	0(0%)	1(100%)	0(0%)	0(-%)	0(0%)	1(100%)
Week 16
n	67	1	40	0	36	1
Normal	67(100%)	0(0%)	40(100%)	0(-%)	36(100%)	0(0%)
High	0(0%)	1(100%)	0(0%)	0(-%)	0(0%)	1(100%)
Week 20
n	64	1	30	0	30	1
Normal	63(98%)	0(0%)	30(100%)	0(-%)	30(100%)	0(0%)
High	1(2%)	1(100%)	0(0%)	0(-%)	0(0%)	1(100%)
Week 24
n	55	1	26	0	30	0
Normal	54(98%)	0(0%)	26(100%)	0(-%)	30(100%)	0(-%)
High	1(2%)	1(100%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 26
n	56	1	24	0	27	0
Normal	55(98%)	0(0%)	24(100%)	0(-%)	27(100%)	0(-%)
High	1(2%)	1(100%)	0(0%)	0(-%)	0(0%)	0(-%)
End of Treatment
n	82	2	79	0	79	1
Normal	81(99%)	0(0%)	78(99%)	0(-%)	79(100%)	0(0%)
High	1(1%)	2(100%)	1(1%)	0(-%)	0(0%)	1(100%)
Gamma Glutamyl Transferase (U/L)
Baseline
n	84	2	80	2	82	2
Normal	84(100%)	0(0%)	80(100%)	0(0%)	82(100%)	0(0%)
High	0(0%)	2(100%)	0(0%)	2(100%)	0(0%)	2(100%)
Week 2
n	82	2	76	2	76	2
Normal	82(100%)	1(50%)	75(99%)	1(50%)	75(99%)	1(50%)
High	0(0%)	1(50%)	1(1%)	1(50%)	1(1%)	1(50%)
Week 4
n	80	2	68	2	70	2
Normal	80(100%)	1(50%)	68(100%)	1(50%)	70(100%)	1(50%)
High	0(0%)	1(50%)	0(0%)	1(50%)	0(0%)	1(50%)
Week 6
n	74	1	61	1	66	1
Normal	74(100%)	0(0%)	61(100%)	1(100%)	66(100%)	0(0%)
High	0(0%)	1(100%)	0(0%)	0(0%)	0(0%)	1(100%)
Week 8
n	72	1	57	1	55	1
Normal	72(100%)	0(0%)	56(98%)	1(100%)	54(98%)	0(0%)
High	0(0%)	1(100%)	1(2%)	0(0%)	1(2%)	1(100%)
Week 12
n	66	1	49	1	49	1
Normal	66(100%)	0(0%)	49(100%)	1(100%)	49(100%)	0(0%)
High	0(0%)	1(100%)	0(0%)	0(0%)	0(0%)	1(100%)
Week 16
n	67	1	39	1	36	1
Normal	67(100%)	1(100%)	39(100%)	1(100%)	36(100%)	0(0%)
High	0(0%)	0(0%)	0(0%)	0(0%)	0(0%)	1(100%)
Week 20
n	65	1	29	1	31	0
Normal	65(100%)	0(0%)	29(100%)	0(0%)	31(100%)	0(-%)
High	0(0%)	1(100%)	0(0%)	1(100%)	0(0%)	0(-%)
Week 24
n	56	1	26	0	29	1
Normal	54(96%)	1(100%)	25(96%)	0(-%)	29(100%)	0(0%)
High	2(4%)	0(0%)	1(4%)	0(-%)	0(0%)	1(100%)
Week 26
n	56	1	24	0	26	1
Normal	55(98%)	1(100%)	23(96%)	0(-%)	26(100%)	0(0%)
High	1(2%)	0(0%)	1(4%)	0(-%)	0(0%)	1(100%)
End of Treatment
n	82	2	78	2	78	2
Normal	80(98%)	1(50%)	77(99%)	1(50%)	78(100%)	1(50%)
High	2(2%)	1(50%)	1(1%)	1(50%)	0(0%)	1(50%)
Alanine Aminotransferase (U/L)
Baseline
n	84	2	81	1	84	0
Normal	84(100%)	0(0%)	81(100%)	0(0%)	84(100%)	0(-%)
High	0(0%)	2(100%)	0(0%)	1(100%)	0(0%)	0(-%)
Week 2
n	81	2	77	1	78	0
Normal	81(100%)	0(0%)	77(100%)	0(0%)	78(100%)	0(-%)
High	0(0%)	2(100%)	0(0%)	1(100%)	0(0%)	0(-%)
Week 4
n	77	2	69	1	72	0
Normal	77(100%)	1(50%)	69(100%)	0(0%)	72(100%)	0(-%)
High	0(0%)	1(50%)	0(0%)	1(100%)	0(0%)	0(-%)
Week 6
n	72	1	59	1	66	0
Normal	71(99%)	1(100%)	59(100%)	0(0%)	66(100%)	0(-%)
High	1(1%)	0(0%)	0(0%)	1(100%)	0(0%)	0(-%)
Week 8
n	71	1	57	1	56	0
Normal	71(100%)	0(0%)	57(100%)	0(0%)	54(96%)	0(-%)
High	0(0%)	1(100%)	0(0%)	1(100%)	2(4%)	0(-%)
Week 12
n	66	1	49	1	50	0
Normal	65(98%)	1(100%)	48(98%)	1(100%)	49(98%)	0(-%)
High	1(2%)	0(0%)	1(2%)	0(0%)	1(2%)	0(-%)
Week 16
n	67	1	40	0	37	0
Normal	67(100%)	1(100%)	40(100%)	0(-%)	37(100%)	0(-%)
High	0(0%)	0(0%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 20
n	64	1	29	0	31	0
Normal	64(100%)	1(100%)	29(100%)	0(-%)	31(100%)	0(-%)
High	0(0%)	0(0%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 24
n	56	1	25	0	30	0
Normal	55(98%)	1(100%)	25(100%)	0(-%)	30(100%)	0(-%)
High	1(2%)	0(0%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 26
n	56	1	24	0	27	0
Normal	56(100%)	1(100%)	23(96%)	0(-%)	27(100%)	0(-%)
High	0(0%)	0(0%)	1(4%)	0(-%)	0(0%)	0(-%)
End of Treatment
n	82	2	79	1	80	0
Normal	81(99%)	1(50%)	79(100%)	1(100%)	80(100%)	0(-%)
High	1(1%)	1(50%)	0(0%)	0(0%)	0(0%)	0(-%)
Aspartate Aminotransferase (U/L)
Baseline
n	84	2	81	1	84	0
Normal	84(100%)	0(0%)	81(100%)	0(0%)	84(100%)	0(-%)
High	0(0%)	2(100%)	0(0%)	1(100%)	0(0%)	0(-%)
Week 2
n	81	2	78	0	78	0
Normal	80(99%)	1(50%)	77(99%)	0(-%)	78(100%)	0(-%)
High	1(1%)	1(50%)	1(1%)	0(-%)	0(0%)	0(-%)
Week 4
n	77	2	69	1	72	0
Normal	76(99%)	1(50%)	69(100%)	1(100%)	72(100%)	0(-%)
High	1(1%)	1(50%)	0(0%)	0(0%)	0(0%)	0(-%)
Week 6
n	72	1	60	0	66	0
Normal	71(99%)	1(100%)	60(100%)	0(-%)	65(98%)	0(-%)
High	1(1%)	0(0%)	0(0%)	0(-%)	1(2%)	0(-%)
Week 8
n	71	1	58	0	56	0
Normal	70(99%)	1(100%)	58(100%)	0(-%)	55(98%)	0(-%)
High	1(1%)	0(0%)	0(0%)	0(-%)	1(2%)	0(-%)
Week 12
n	66	1	50	0	50	0
Normal	65(98%)	1(100%)	49(98%)	0(-%)	50(100%)	0(-%)
High	1(2%)	0(0%)	1(2%)	0(-%)	0(0%)	0(-%)
Week 16
n	67	1	40	0	37	0
Normal	67(100%)	1(100%)	39(98%)	0(-%)	37(100%)	0(-%)
High	0(0%)	0(0%)	1(3%)	0(-%)	0(0%)	0(-%)
Week 20
n	64	1	29	0	31	0
Normal	64(100%)	1(100%)	29(100%)	0(-%)	31(100%)	0(-%)
High	0(0%)	0(0%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 24
n	56	1	25	0	30	0
Normal	54(96%)	1(100%)	24(96%)	0(-%)	30(100%)	0(-%)
High	2(4%)	0(0%)	1(4%)	0(-%)	0(0%)	0(-%)
Week 26
n	56	1	24	0	27	0
Normal	55(98%)	1(100%)	23(96%)	0(-%)	27(100%)	0(-%)
High	1(2%)	0(0%)	1(4%)	0(-%)	0(0%)	0(-%)
End of Treatment
n	82	2	79	1	80	0
Normal	80(98%)	1(50%)	78(99%)	1(100%)	80(100%)	0(-%)
High	2(2%)	1(50%)	1(1%)	0(0%)	0(0%)	0(-%)
Blood Urea Nitrogen (mmol/L)
Baseline
n	86	0	80	2	84	0
Normal	86(100%)	0(-%)	80(100%)	0(0%)	84(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	2(100%)	0(0%)	0(-%)
Week 2
n	84	0	76	2	78	0
Normal	84(100%)	0(-%)	76(100%)	2(100%)	77(99%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(0%)	1(1%)	0(-%)
Week 4
n	82	0	68	2	72	0
Normal	82(100%)	0(-%)	68(100%)	2(100%)	72(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(0%)	0(0%)	0(-%)
Week 6
n	75	0	60	2	67	0
Normal	75(100%)	0(-%)	60(100%)	2(100%)	67(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(0%)	0(0%)	0(-%)
Week 8
n	73	0	56	2	56	0
Normal	73(100%)	0(-%)	56(100%)	2(100%)	56(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(0%)	0(0%)	0(-%)
Week 12
n	67	0	49	1	50	0
Normal	67(100%)	0(-%)	49(100%)	1(100%)	50(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(0%)	0(0%)	0(-%)
Week 16
n	68	0	39	1	37	0
Normal	68(100%)	0(-%)	39(100%)	1(100%)	37(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(0%)	0(0%)	0(-%)
Week 20
n	66	0	29	1	31	0
Normal	66(100%)	0(-%)	29(100%)	1(100%)	31(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(0%)	0(0%)	0(-%)
Week 24
n	57	0	25	1	30	0
Normal	57(100%)	0(-%)	25(100%)	1(100%)	30(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(0%)	0(0%)	0(-%)
Week 26
n	57	0	23	1	27	0
Normal	57(100%)	0(-%)	23(100%)	1(100%)	26(96%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(0%)	1(4%)	0(-%)
End of Treatment
n	84	0	78	2	80	0
Normal	84(100%)	0(-%)	78(100%)	2(100%)	79(99%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(0%)	1(1%)	0(-%)
Creatinine (umol/L)
Baseline
n	86	0	82	0	84	0
Normal	86(100%)	0(-%)	82(100%)	0(-%)	84(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 2
n	84	0	78	0	78	0
Normal	84(100%)	0(-%)	78(100%)	0(-%)	78(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 4
n	82	0	70	0	72	0
Normal	82(100%)	0(-%)	70(100%)	0(-%)	72(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 6
n	75	0	62	0	67	0
Normal	75(100%)	0(-%)	62(100%)	0(-%)	67(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 8
n	73	0	58	0	56	0
Normal	73(100%)	0(-%)	58(100%)	0(-%)	56(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 12
n	67	0	50	0	50	0
Normal	67(100%)	0(-%)	50(100%)	0(-%)	50(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 16
n	68	0	40	0	37	0
Normal	68(100%)	0(-%)	40(100%)	0(-%)	37(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 20
n	66	0	30	0	31	0
Normal	66(100%)	0(-%)	30(100%)	0(-%)	31(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 24
n	57	0	26	0	30	0
Normal	57(100%)	0(-%)	26(100%)	0(-%)	30(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 26
n	57	0	24	0	27	0
Normal	57(100%)	0(-%)	24(100%)	0(-%)	27(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
End of Treatment
n	84	0	80	0	80	0
Normal	84(100%)	0(-%)	80(100%)	0(-%)	80(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Urate (umol/L)
Baseline
n	86	0	82	0	84	0
Normal	86(100%)	0(-%)	82(100%)	0(-%)	84(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 2
n	84	0	78	0	78	0
Normal	84(100%)	0(-%)	78(100%)	0(-%)	78(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 4
n	82	0	70	0	72	0
Normal	82(100%)	0(-%)	70(100%)	0(-%)	72(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 6
n	75	0	62	0	67	0
Normal	75(100%)	0(-%)	62(100%)	0(-%)	67(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 8
n	73	0	58	0	56	0
Normal	73(100%)	0(-%)	58(100%)	0(-%)	56(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 12
n	67	0	50	0	50	0
Normal	67(100%)	0(-%)	50(100%)	0(-%)	50(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 16
n	68	0	40	0	37	0
Normal	68(100%)	0(-%)	40(100%)	0(-%)	37(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 20
n	66	0	30	0	31	0
Normal	66(100%)	0(-%)	30(100%)	0(-%)	31(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 24
n	57	0	26	0	30	0
Normal	57(100%)	0(-%)	26(100%)	0(-%)	30(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 26
n	57	0	24	0	27	0
Normal	57(100%)	0(-%)	24(100%)	0(-%)	27(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
End of Treatment
n	84	0	80	0	80	0
Normal	84(100%)	0(-%)	80(100%)	0(-%)	80(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Phosphate (mmol/L)
Baseline
n	86	0	81	0	83	0
Normal	86(100%)	0(-%)	81(100%)	0(-%)	83(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 2
n	84	0	78	0	78	0
Normal	84(100%)	0(-%)	78(100%)	0(-%)	78(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 4
n	82	0	68	0	72	0
Normal	82(100%)	0(-%)	68(100%)	0(-%)	72(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 6
n	75	0	62	0	67	0
Normal	75(100%)	0(-%)	62(100%)	0(-%)	67(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 8
n	73	0	58	0	56	0
Normal	73(100%)	0(-%)	58(100%)	0(-%)	56(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 12
n	67	0	50	0	50	0
Normal	67(100%)	0(-%)	50(100%)	0(-%)	50(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 16
n	68	0	40	0	37	0
Normal	68(100%)	0(-%)	40(100%)	0(-%)	37(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 20
n	65	0	30	0	31	0
Normal	65(100%)	0(-%)	30(100%)	0(-%)	31(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 24
n	56	0	26	0	30	0
Normal	56(100%)	0(-%)	26(100%)	0(-%)	30(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 26
n	57	0	24	0	27	0
Normal	57(100%)	0(-%)	24(100%)	0(-%)	27(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
End of Treatment
n	84	0	79	0	80	0
Normal	84(100%)	0(-%)	79(100%)	0(-%)	80(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Calcium (mmol/L)
Baseline
n	86	0	82	0	84	0
Normal	86(100%)	0(-%)	82(100%)	0(-%)	84(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 2
n	84	0	78	0	78	0
Normal	84(100%)	0(-%)	78(100%)	0(-%)	78(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 4
n	82	0	70	0	72	0
Normal	82(100%)	0(-%)	70(100%)	0(-%)	72(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 6
n	75	0	62	0	67	0
Normal	75(100%)	0(-%)	62(100%)	0(-%)	67(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 8
n	73	0	58	0	56	0
Normal	73(100%)	0(-%)	58(100%)	0(-%)	56(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 12
n	67	0	50	0	50	0
Normal	67(100%)	0(-%)	50(100%)	0(-%)	50(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 16
n	68	0	40	0	37	0
Normal	68(100%)	0(-%)	40(100%)	0(-%)	37(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 20
n	66	0	30	0	31	0
Normal	66(100%)	0(-%)	30(100%)	0(-%)	31(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 24
n	57	0	26	0	30	0
Normal	57(100%)	0(-%)	26(100%)	0(-%)	30(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 26
n	57	0	24	0	27	0
Normal	57(100%)	0(-%)	24(100%)	0(-%)	27(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
End of Treatment
n	84	0	80	0	80	0
Normal	84(100%)	0(-%)	80(100%)	0(-%)	80(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Glucose (mmol/L)
Baseline
n	85	1	82	0	84	0
Normal	85(100%)	0(0%)	82(100%)	0(-%)	84(100%)	0(-%)
High	0(0%)	1(100%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 2
n	82	1	78	0	78	0
Normal	82(100%)	1(100%)	78(100%)	0(-%)	77(99%)	0(-%)
High	0(0%)	0(0%)	0(0%)	0(-%)	1(1%)	0(-%)
Week 4
n	78	1	69	0	72	0
Normal	78(100%)	1(100%)	68(99%)	0(-%)	72(100%)	0(-%)
High	0(0%)	0(0%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 6
n	72	1	60	0	66	0
Normal	72(100%)	1(100%)	60(100%)	0(-%)	65(98%)	0(-%)
High	0(0%)	0(0%)	0(0%)	0(-%)	1(2%)	0(-%)
Week 8
n	71	1	57	0	56	0
Normal	71(100%)	1(100%)	57(100%)	0(-%)	56(100%)	0(-%)
High	0(0%)	0(0%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 12
n	66	1	50	0	49	0
Normal	66(100%)	1(100%)	49(98%)	0(-%)	49(100%)	0(-%)
High	0(0%)	0(0%)	1(2%)	0(-%)	0(0%)	0(-%)
Week 16
n	67	1	40	0	37	0
Normal	67(100%)	1(100%)	40(100%)	0(-%)	37(100%)	0(-%)
High	0(0%)	0(0%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 20
n	64	1	29	0	31	0
Normal	64(100%)	1(100%)	29(100%)	0(-%)	31(100%)	0(-%)
High	0(0%)	0(0%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 24
n	56	1	25	0	30	0
Normal	56(100%)	1(100%)	25(100%)	0(-%)	30(100%)	0(-%)
High	0(0%)	0(0%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 26
n	56	1	24	0	27	0
Normal	56(100%)	1(100%)	24(100%)	0(-%)	27(100%)	0(-%)
High	0(0%)	0(0%)	0(0%)	0(-%)	0(0%)	0(-%)
End of Treatment
n	83	1	80	0	80	0
Normal	83(100%)	1(100%)	80(100%)	0(-%)	80(100%)	0(-%)
High	0(0%)	0(0%)	0(0%)	0(-%)	0(0%)	0(-%)
Protein (g/L)
Baseline
n	86	0	82	0	84	0
Normal	86(100%)	0(-%)	82(100%)	0(-%)	84(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 2
n	84	0	78	0	78	0
Normal	84(100%)	0(-%)	78(100%)	0(-%)	78(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 4
n	82	0	70	0	72	0
Normal	82(100%)	0(-%)	70(100%)	0(-%)	72(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 6
n	75	0	62	0	67	0
Normal	75(100%)	0(-%)	62(100%)	0(-%)	67(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 8
n	73	0	58	0	56	0
Normal	73(100%)	0(-%)	58(100%)	0(-%)	56(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 12
n	67	0	50	0	50	0
Normal	67(100%)	0(-%)	50(100%)	0(-%)	50(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 16
n	68	0	40	0	37	0
Normal	68(100%)	0(-%)	40(100%)	0(-%)	37(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 20
n	66	0	30	0	31	0
Normal	66(100%)	0(-%)	30(100%)	0(-%)	31(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 24
n	57	0	26	0	30	0
Normal	57(100%)	0(-%)	26(100%)	0(-%)	30(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 26
n	57	0	24	0	27	0
Normal	57(100%)	0(-%)	24(100%)	0(-%)	27(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
End of Treatment
n	84	0	80	0	80	0
Normal	84(100%)	0(-%)	80(100%)	0(-%)	80(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Albumin (g/L)
Baseline
n	86	0	82	0	84	0
Normal	86(100%)	0(-%)	82(100%)	0(-%)	84(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 2
n	83	0	78	0	78	0
Normal	83(100%)	0(-%)	78(100%)	0(-%)	78(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 4
n	79	0	70	0	72	0
Normal	79(100%)	0(-%)	70(100%)	0(-%)	72(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 6
n	73	0	60	0	66	0
Normal	73(100%)	0(-%)	60(100%)	0(-%)	66(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 8
n	72	0	58	0	56	0
Normal	72(100%)	0(-%)	58(100%)	0(-%)	56(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 12
n	67	0	50	0	50	0
Normal	67(100%)	0(-%)	50(100%)	0(-%)	50(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 16
n	68	0	40	0	37	0
Normal	68(100%)	0(-%)	40(100%)	0(-%)	37(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 20
n	65	0	29	0	31	0
Normal	65(100%)	0(-%)	29(100%)	0(-%)	31(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 24
n	57	0	25	0	30	0
Normal	57(100%)	0(-%)	25(100%)	0(-%)	30(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 26
n	57	0	24	0	27	0
Normal	57(100%)	0(-%)	24(100%)	0(-%)	27(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
End of Treatment
n	84	0	80	0	80	0
Normal	84(100%)	0(-%)	80(100%)	0(-%)	80(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Cholesterol (mmol/L)
Baseline
n	86	0	82	0	84	0
Normal	86(100%)	0(-%)	82(100%)	0(-%)	84(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 2
n	84	0	78	0	78	0
Normal	84(100%)	0(-%)	78(100%)	0(-%)	78(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 4
n	82	0	70	0	72	0
Normal	82(100%)	0(-%)	70(100%)	0(-%)	72(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 6
n	75	0	62	0	67	0
Normal	75(100%)	0(-%)	62(100%)	0(-%)	67(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 8
n	73	0	58	0	56	0
Normal	73(100%)	0(-%)	58(100%)	0(-%)	56(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 12
n	67	0	50	0	50	0
Normal	67(100%)	0(-%)	50(100%)	0(-%)	50(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 16
n	68	0	40	0	37	0
Normal	68(100%)	0(-%)	40(100%)	0(-%)	37(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 20
n	66	0	30	0	31	0
Normal	66(100%)	0(-%)	30(100%)	0(-%)	31(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 24
n	57	0	26	0	30	0
Normal	57(100%)	0(-%)	26(100%)	0(-%)	30(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 26
n	57	0	24	0	27	0
Normal	57(100%)	0(-%)	24(100%)	0(-%)	27(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
End of Treatment
n	84	0	80	0	80	0
Normal	84(100%)	0(-%)	80(100%)	0(-%)	80(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Creatine Kinase (U/L)
Baseline
n	86	0	81	1	81	3
Normal	86(100%)	0(-%)	81(100%)	0(0%)	81(100%)	0(0%)
High	0(0%)	0(-%)	0(0%)	1(100%)	0(0%)	3(100%)
Week 2
n	83	0	77	1	75	3
Normal	81(98%)	0(-%)	74(96%)	1(100%)	74(99%)	3(100%)
High	2(2%)	0(-%)	3(4%)	0(0%)	1(1%)	0(0%)
Week 4
n	79	0	69	1	69	3
Normal	78(99%)	0(-%)	68(99%)	1(100%)	68(99%)	3(100%)
High	1(1%)	0(-%)	1(1%)	0(0%)	1(1%)	0(0%)
Week 6
n	73	0	59	1	63	3
Normal	73(100%)	0(-%)	58(98%)	1(100%)	61(97%)	2(67%)
High	0(0%)	0(-%)	1(2%)	0(0%)	2(3%)	1(33%)
Week 8
n	72	0	57	1	54	2
Normal	71(99%)	0(-%)	57(100%)	1(100%)	53(98%)	2(100%)
High	1(1%)	0(-%)	0(0%)	0(0%)	1(2%)	0(0%)
Week 12
n	67	0	49	1	48	2
Normal	65(97%)	0(-%)	48(98%)	1(100%)	47(98%)	1(50%)
High	2(3%)	0(-%)	1(2%)	0(0%)	1(2%)	1(50%)
Week 16
n	68	0	39	1	36	1
Normal	66(97%)	0(-%)	39(100%)	1(100%)	36(100%)	1(100%)
High	2(3%)	0(-%)	0(0%)	0(0%)	0(0%)	0(0%)
Week 20
n	65	0	29	0	30	1
Normal	65(100%)	0(-%)	27(93%)	0(-%)	29(97%)	1(100%)
High	0(0%)	0(-%)	2(7%)	0(-%)	1(3%)	0(0%)
Week 24
n	57	0	25	0	29	1
Normal	55(96%)	0(-%)	25(100%)	0(-%)	29(100%)	1(100%)
High	2(4%)	0(-%)	0(0%)	0(-%)	0(0%)	0(0%)
Week 26
n	57	0	24	0	26	1
Normal	57(100%)	0(-%)	24(100%)	0(-%)	25(96%)	1(100%)
High	0(0%)	0(-%)	0(0%)	0(-%)	1(4%)	0(0%)
End of Treatment
n	84	0	79	1	77	3
Normal	82(98%)	0(-%)	76(96%)	1(100%)	76(99%)	3(100%)
High	2(2%)	0(-%)	3(4%)	0(0%)	1(1%)	0(0%)
Hematology
Hemoglobin (mmol/L)
Baseline
n	85	0	81	0	81	0
Normal	85(100%)	0(-%)	81(100%)	0(-%)	81(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 2
n	82	0	77	0	77	0
Normal	82(100%)	0(-%)	77(100%)	0(-%)	77(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 4
n	78	0	69	0	69	0
Normal	78(100%)	0(-%)	69(100%)	0(-%)	69(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 6
n	72	0	59	0	63	0
Normal	72(100%)	0(-%)	59(100%)	0(-%)	63(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 8
n	71	0	56	0	55	0
Normal	71(100%)	0(-%)	56(100%)	0(-%)	55(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 12
n	65	0	48	0	49	0
Normal	65(100%)	0(-%)	48(100%)	0(-%)	49(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 16
n	67	0	39	0	36	0
Normal	67(100%)	0(-%)	39(100%)	0(-%)	36(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 20
n	64	0	29	0	31	0
Normal	64(100%)	0(-%)	29(100%)	0(-%)	31(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 24
n	57	0	24	0	29	0
Normal	57(100%)	0(-%)	24(100%)	0(-%)	29(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 26
n	56	0	24	0	26	0
Normal	56(100%)	0(-%)	24(100%)	0(-%)	26(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
End of Treatment
n	83	0	79	0	78	0
Normal	83(100%)	0(-%)	79(100%)	0(-%)	78(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Hematocrit
Baseline
n	85	0	80	0	80	0
Normal	85(100%)	0(-%)	80(100%)	0(-%)	80(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 2
n	82	0	76	0	76	0
Normal	82(100%)	0(-%)	76(100%)	0(-%)	76(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 4
n	76	0	67	0	67	0
Normal	76(100%)	0(-%)	67(100%)	0(-%)	67(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 6
n	71	0	57	0	63	0
Normal	71(100%)	0(-%)	57(100%)	0(-%)	63(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 8
n	70	0	53	0	55	0
Normal	70(100%)	0(-%)	53(100%)	0(-%)	55(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 12
n	64	0	47	0	49	0
Normal	64(100%)	0(-%)	47(100%)	0(-%)	49(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 16
n	67	0	39	0	36	0
Normal	67(100%)	0(-%)	39(100%)	0(-%)	36(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 20
n	63	0	29	0	31	0
Normal	63(100%)	0(-%)	29(100%)	0(-%)	31(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 24
n	57	0	24	0	29	0
Normal	57(100%)	0(-%)	24(100%)	0(-%)	29(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 26
n	55	0	24	0	26	0
Normal	55(100%)	0(-%)	24(100%)	0(-%)	26(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
End of Treatment
n	82	0	78	0	77	0
Normal	82(100%)	0(-%)	78(100%)	0(-%)	77(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Ery. Mean Corpuscular Volume (fL)
Baseline
n	85	0	80	0	80	0
Normal	85(100%)	0(-%)	80(100%)	0(-%)	80(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 2
n	82	0	76	0	76	0
Normal	82(100%)	0(-%)	76(100%)	0(-%)	76(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 4
n	76	0	67	0	67	0
Normal	76(100%)	0(-%)	67(100%)	0(-%)	67(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 6
n	71	0	57	0	63	0
Normal	71(100%)	0(-%)	57(100%)	0(-%)	63(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 8
n	70	0	53	0	55	0
Normal	70(100%)	0(-%)	53(100%)	0(-%)	55(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 12
n	64	0	47	0	49	0
Normal	64(100%)	0(-%)	47(100%)	0(-%)	49(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 16
n	67	0	39	0	36	0
Normal	67(100%)	0(-%)	39(100%)	0(-%)	36(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 20
n	63	0	29	0	31	0
Normal	63(100%)	0(-%)	29(100%)	0(-%)	31(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 24
n	57	0	24	0	29	0
Normal	57(100%)	0(-%)	24(100%)	0(-%)	29(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 26
n	55	0	24	0	26	0
Normal	55(100%)	0(-%)	24(100%)	0(-%)	26(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
End of Treatment
n	82	0	78	0	77	0
Normal	82(100%)	0(-%)	78(100%)	0(-%)	77(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Ery. Mean Corpuscular Hemoglobin (fmol(Fe))
Baseline
n	85	0	81	0	81	0
Normal	85(100%)	0(-%)	81(100%)	0(-%)	81(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 2
n	82	0	77	0	77	0
Normal	82(100%)	0(-%)	77(100%)	0(-%)	77(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 4
n	78	0	69	0	69	0
Normal	78(100%)	0(-%)	69(100%)	0(-%)	69(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 6
n	72	0	59	0	63	0
Normal	72(100%)	0(-%)	59(100%)	0(-%)	63(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 8
n	71	0	56	0	55	0
Normal	71(100%)	0(-%)	56(100%)	0(-%)	55(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 12
n	65	0	48	0	49	0
Normal	65(100%)	0(-%)	48(100%)	0(-%)	49(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 16
n	67	0	39	0	36	0
Normal	67(100%)	0(-%)	39(100%)	0(-%)	36(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 20
n	64	0	29	0	31	0
Normal	64(100%)	0(-%)	29(100%)	0(-%)	31(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 24
n	57	0	24	0	29	0
Normal	57(100%)	0(-%)	24(100%)	0(-%)	29(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 26
n	56	0	24	0	26	0
Normal	56(100%)	0(-%)	24(100%)	0(-%)	26(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
End of Treatment
n	83	0	79	0	78	0
Normal	83(100%)	0(-%)	79(100%)	0(-%)	78(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Ery. Mean Corpuscular HGB Concentration (mmol/L)
Baseline
n	85	0	80	0	80	0
Normal	85(100%)	0(-%)	80(100%)	0(-%)	80(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 2
n	82	0	76	0	76	0
Normal	82(100%)	0(-%)	76(100%)	0(-%)	76(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 4
n	76	0	67	0	67	0
Normal	76(100%)	0(-%)	67(100%)	0(-%)	67(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 6
n	71	0	57	0	63	0
Normal	71(100%)	0(-%)	57(100%)	0(-%)	63(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 8
n	70	0	53	0	55	0
Normal	70(100%)	0(-%)	53(100%)	0(-%)	55(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 12
n	64	0	47	0	49	0
Normal	64(100%)	0(-%)	47(100%)	0(-%)	49(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 16
n	67	0	39	0	36	0
Normal	67(100%)	0(-%)	39(100%)	0(-%)	36(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 20
n	63	0	29	0	31	0
Normal	63(100%)	0(-%)	29(100%)	0(-%)	31(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 24
n	57	0	24	0	29	0
Normal	57(100%)	0(-%)	24(100%)	0(-%)	29(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 26
n	55	0	24	0	26	0
Normal	55(100%)	0(-%)	24(100%)	0(-%)	26(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
End of Treatment
n	82	0	78	0	77	0
Normal	82(100%)	0(-%)	78(100%)	0(-%)	77(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Leukocytes (GI/L)
Baseline
n	85	0	81	0	81	0
Normal	85(100%)	0(-%)	81(100%)	0(-%)	81(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 2
n	82	0	77	0	77	0
Normal	82(100%)	0(-%)	77(100%)	0(-%)	77(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 4
n	78	0	69	0	69	0
Normal	78(100%)	0(-%)	69(100%)	0(-%)	69(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 6
n	72	0	59	0	63	0
Normal	72(100%)	0(-%)	59(100%)	0(-%)	63(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 8
n	71	0	56	0	55	0
Normal	71(100%)	0(-%)	56(100%)	0(-%)	55(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 12
n	65	0	48	0	49	0
Normal	65(100%)	0(-%)	48(100%)	0(-%)	49(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 16
n	67	0	39	0	36	0
Normal	67(100%)	0(-%)	39(100%)	0(-%)	36(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 20
n	64	0	29	0	31	0
Normal	64(100%)	0(-%)	29(100%)	0(-%)	31(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 24
n	57	0	24	0	29	0
Normal	57(100%)	0(-%)	24(100%)	0(-%)	29(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 26
n	56	0	24	0	26	0
Normal	56(100%)	0(-%)	24(100%)	0(-%)	26(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
End of Treatment
n	83	0	79	0	78	0
Normal	83(100%)	0(-%)	79(100%)	0(-%)	78(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Lymphocytes (GI/L)
Baseline
n	85	0	81	0	81	0
Normal	85(100%)	0(-%)	81(100%)	0(-%)	81(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 2
n	82	0	77	0	77	0
Normal	82(100%)	0(-%)	77(100%)	0(-%)	77(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 4
n	78	0	69	0	69	0
Normal	78(100%)	0(-%)	69(100%)	0(-%)	69(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 6
n	72	0	59	0	62	0
Normal	72(100%)	0(-%)	59(100%)	0(-%)	62(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 8
n	71	0	56	0	55	0
Normal	70(99%)	0(-%)	56(100%)	0(-%)	55(100%)	0(-%)
High	1(1%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 12
n	65	0	48	0	49	0
Normal	64(98%)	0(-%)	48(100%)	0(-%)	49(100%)	0(-%)
High	1(2%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 16
n	67	0	39	0	36	0
Normal	67(100%)	0(-%)	39(100%)	0(-%)	36(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 20
n	64	0	29	0	31	0
Normal	64(100%)	0(-%)	29(100%)	0(-%)	31(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 24
n	57	0	24	0	29	0
Normal	57(100%)	0(-%)	24(100%)	0(-%)	29(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 26
n	56	0	24	0	26	0
Normal	56(100%)	0(-%)	24(100%)	0(-%)	26(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
End of Treatment
n	83	0	79	0	78	0
Normal	83(100%)	0(-%)	79(100%)	0(-%)	78(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Monocytes (GI/L)
Baseline
n	85	0	81	0	81	0
Normal	85(100%)	0(-%)	81(100%)	0(-%)	81(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 2
n	82	0	77	0	77	0
Normal	82(100%)	0(-%)	77(100%)	0(-%)	77(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 4
n	78	0	69	0	69	0
Normal	78(100%)	0(-%)	69(100%)	0(-%)	69(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 6
n	72	0	59	0	62	0
Normal	71(99%)	0(-%)	59(100%)	0(-%)	62(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 8
n	71	0	56	0	55	0
Normal	71(100%)	0(-%)	56(100%)	0(-%)	55(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 12
n	65	0	48	0	49	0
Normal	65(100%)	0(-%)	48(100%)	0(-%)	49(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 16
n	67	0	39	0	36	0
Normal	66(99%)	0(-%)	39(100%)	0(-%)	36(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 20
n	64	0	29	0	31	0
Normal	64(100%)	0(-%)	29(100%)	0(-%)	31(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 24
n	57	0	24	0	29	0
Normal	57(100%)	0(-%)	24(100%)	0(-%)	29(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 26
n	56	0	24	0	26	0
Normal	56(100%)	0(-%)	24(100%)	0(-%)	26(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
End of Treatment
n	83	0	79	0	78	0
Normal	83(100%)	0(-%)	79(100%)	0(-%)	78(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Eosinophils (GI/L)
Baseline
n	85	0	80	1	81	0
Normal	85(100%)	0(-%)	80(100%)	0(0%)	81(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	1(100%)	0(0%)	0(-%)
Week 2
n	82	0	76	1	77	0
Normal	82(100%)	0(-%)	74(97%)	1(100%)	77(100%)	0(-%)
High	0(0%)	0(-%)	2(3%)	0(0%)	0(0%)	0(-%)
Week 4
n	78	0	69	0	69	0
Normal	78(100%)	0(-%)	69(100%)	0(-%)	68(99%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	1(1%)	0(-%)
Week 6
n	72	0	59	0	62	0
Normal	72(100%)	0(-%)	59(100%)	0(-%)	58(94%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	4(6%)	0(-%)
Week 8
n	71	0	56	0	55	0
Normal	71(100%)	0(-%)	53(95%)	0(-%)	52(95%)	0(-%)
High	0(0%)	0(-%)	3(5%)	0(-%)	3(5%)	0(-%)
Week 12
n	65	0	48	0	49	0
Normal	65(100%)	0(-%)	46(96%)	0(-%)	49(100%)	0(-%)
High	0(0%)	0(-%)	2(4%)	0(-%)	0(0%)	0(-%)
Week 16
n	67	0	39	0	36	0
Normal	67(100%)	0(-%)	39(100%)	0(-%)	35(97%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	1(3%)	0(-%)
Week 20
n	64	0	29	0	31	0
Normal	64(100%)	0(-%)	29(100%)	0(-%)	31(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 24
n	57	0	24	0	29	0
Normal	57(100%)	0(-%)	24(100%)	0(-%)	29(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 26
n	56	0	24	0	26	0
Normal	56(100%)	0(-%)	24(100%)	0(-%)	26(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
End of Treatment
n	83	0	78	1	78	0
Normal	83(100%)	0(-%)	78(100%)	1(100%)	76(97%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(0%)	2(3%)	0(-%)
Basophils (GI/L)
Baseline
n	85	0	81	0	81	0
Normal	85(100%)	0(-%)	81(100%)	0(-%)	81(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 2
n	82	0	77	0	77	0
Normal	82(100%)	0(-%)	77(100%)	0(-%)	77(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 4
n	78	0	69	0	69	0
Normal	78(100%)	0(-%)	69(100%)	0(-%)	69(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 6
n	72	0	59	0	62	0
Normal	72(100%)	0(-%)	59(100%)	0(-%)	62(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 8
n	71	0	56	0	55	0
Normal	71(100%)	0(-%)	56(100%)	0(-%)	55(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 12
n	65	0	48	0	49	0
Normal	65(100%)	0(-%)	48(100%)	0(-%)	49(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 16
n	67	0	39	0	36	0
Normal	67(100%)	0(-%)	39(100%)	0(-%)	36(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 20
n	64	0	29	0	31	0
Normal	64(100%)	0(-%)	29(100%)	0(-%)	31(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 24
n	57	0	24	0	29	0
Normal	57(100%)	0(-%)	24(100%)	0(-%)	29(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 26
n	56	0	24	0	26	0
Normal	56(100%)	0(-%)	24(100%)	0(-%)	26(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
End of Treatment
n	83	0	79	0	78	0
Normal	83(100%)	0(-%)	79(100%)	0(-%)	78(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Platelet (GI/L)
Baseline
n	84	0	79	0	81	0
Normal	84(100%)	0(-%)	79(100%)	0(-%)	81(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 2
n	82	0	74	0	77	0
Normal	82(100%)	0(-%)	74(100%)	0(-%)	77(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 4
n	77	0	67	0	68	0
Normal	77(100%)	0(-%)	67(100%)	0(-%)	68(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 6
n	72	0	57	0	61	0
Normal	72(100%)	0(-%)	57(100%)	0(-%)	61(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 8
n	71	0	55	0	54	0
Normal	71(100%)	0(-%)	55(100%)	0(-%)	54(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 12
n	64	0	47	0	48	0
Normal	64(100%)	0(-%)	47(100%)	0(-%)	48(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 16
n	67	0	37	0	36	0
Normal	67(100%)	0(-%)	37(100%)	0(-%)	36(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 20
n	64	0	28	0	30	0
Normal	64(100%)	0(-%)	28(100%)	0(-%)	30(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 24
n	56	0	22	0	28	0
Normal	56(100%)	0(-%)	22(100%)	0(-%)	28(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 26
n	55	0	23	0	26	0
Normal	55(100%)	0(-%)	23(100%)	0(-%)	26(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
End of Treatment
n	83	0	77	0	78	0
Normal	83(100%)	0(-%)	77(100%)	0(-%)	78(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Erythrocytes (TI/L)
Baseline
n	85	0	81	0	81	0
Normal	85(100%)	0(-%)	81(100%)	0(-%)	81(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 2
n	82	0	77	0	77	0
Normal	82(100%)	0(-%)	77(100%)	0(-%)	77(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 4
n	78	0	69	0	69	0
Normal	78(100%)	0(-%)	69(100%)	0(-%)	69(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 6
n	72	0	59	0	63	0
Normal	72(100%)	0(-%)	59(100%)	0(-%)	63(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 8
n	71	0	56	0	55	0
Normal	71(100%)	0(-%)	56(100%)	0(-%)	55(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 12
n	65	0	48	0	49	0
Normal	65(100%)	0(-%)	48(100%)	0(-%)	49(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 16
n	67	0	39	0	36	0
Normal	67(100%)	0(-%)	39(100%)	0(-%)	36(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 20
n	64	0	29	0	31	0
Normal	64(100%)	0(-%)	29(100%)	0(-%)	31(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 24
n	57	0	24	0	29	0
Normal	57(100%)	0(-%)	24(100%)	0(-%)	29(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
Week 26
n	56	0	24	0	26	0
Normal	56(100%)	0(-%)	24(100%)	0(-%)	26(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)
End of Treatment
n	83	0	79	0	78	0
Normal	83(100%)	0(-%)	79(100%)	0(-%)	78(100%)	0(-%)
High	0(0%)	0(-%)	0(0%)	0(-%)	0(0%)	0(-%)

NOTES: Only subjects with baseline results are included in the summary.

There were no subjects with abnormal low values at baseline.

Program: t-14-6-04.sas

Program `t-14-6-04.sas`

Version 1, written from Clinwright's patterns, 2026-10-17, checks passed.

/*==== 00-header ====*/
/*----------------------------------------------------------------------------
  Output  : Table 14-6.04 / Shifts of Laboratory Values During Treatment, Categorized Based on Threshold Ranges, by Visit / Safety Analysis Set
  Program : t-14-6-04.sas   Reporting effort : CSR
  ADaM    : /work/adam (ADSL, ADADAS, ADCIBC, ADLBC, ADLBH, ADNPIX, ADTTE, ADVS, ADAE, ADCM, ADMH, ADEX)
  The header and the report step follow from the shell. The sections between
  them make WORK.FINAL, one record per row of the table, in order:
    _page     the page (1 unless the output is paged); _pagelbl its heading or empty
    _ord      the row's order; _indent the label's indentation (0 = flush left)
    _rowid    the uuid of the shell row it shows (WORK._SHELL); one shell row may
              have several (a category per value); a blank row's is blank-<n>
    _kind     label | stat | blank
    rowlabel  the row's label, as text
    col1      Normal at|Baseline
    col2      High at|Baseline
    col3      Normal at|Baseline
    col4      High at|Baseline
    col5      Normal at|Baseline
    col6      High at|Baseline
  and set the big N of the column headers:
    &_bign1_2  Placebo|(N=xx)
    &_bign3_4  Xan. Low|(N=xx)
    &_bign5_6  Xan. High|(N=xx)
  /work/_lib/clinwright.sas has %ls_bign, %ls_count, %ls_stats, %ls_npct, %ls_num.
----------------------------------------------------------------------------*/
libname adam "/work/adam" access=readonly;
%include "/work/_lib/clinwright.sas";
%ls_setup;

/* The shell's rows, in order, with each column's value pattern (_xx1-_xx6). */
data work._shell;
  length _page 8 _pagelbl $200 _ord 8 _indent 8 _rowid $36 _kind $5 _var $32 rowlabel $200 _xx1 $40 _xx2 $40 _xx3 $40 _xx4 $40 _xx5 $40 _xx6 $40;
  _page = 1; _pagelbl = '';
  _ord=1; _indent=0; _rowid='8ce37f8d-5804-479c-8428-50933aa07917'; _kind='label'; _var=''; rowlabel='[Category]'; _xx1=''; _xx2=''; _xx3=''; _xx4=''; _xx5=''; _xx6=''; output;
  _ord=2; _indent=1; _rowid='5dc3c63d-d230-4269-aad6-f7543bccdc31'; _kind='label'; _var=''; rowlabel='[Parameter]'; _xx1=''; _xx2=''; _xx3=''; _xx4=''; _xx5=''; _xx6=''; output;
  _ord=3; _indent=2; _rowid='b2c89fb4-7afb-42e3-bde7-00ac49bceb99'; _kind='label'; _var=''; rowlabel='[Visit]'; _xx1=''; _xx2=''; _xx3=''; _xx4=''; _xx5=''; _xx6=''; output;
  _ord=4; _indent=3; _rowid='67a6ff4e-c408-4077-b930-19b20737cb95'; _kind='stat'; _var=''; rowlabel='n'; _xx1='xx'; _xx2='xx'; _xx3='xx'; _xx4='xx'; _xx5='xx'; _xx6='xx'; output;
  _ord=5; _indent=3; _rowid='9412188f-b16e-4e64-9f5c-2073fc87a708'; _kind='stat'; _var=''; rowlabel='Normal'; _xx1='xx(xx%)'; _xx2='xx(xx%)'; _xx3='xx(xx%)'; _xx4='xx(xx%)'; _xx5='xx(xx%)'; _xx6='xx(xx%)'; output;
  _ord=6; _indent=3; _rowid='ae6f2cb6-a1aa-472a-8ab4-795b101fc560'; _kind='stat'; _var=''; rowlabel='High'; _xx1='xx(xx%)'; _xx2='xx(xx%)'; _xx3='xx(xx%)'; _xx4='xx(xx%)'; _xx5='xx(xx%)'; _xx6='xx(xx%)'; output;
run;

/*==== 10-data ====*/
/* Made from the output's analysis: the records of ADLBC with strip(AVISIT) ne '.' and index(PARAMCD, '_') = 0 of the subjects of ADSL with SAFFL = 'Y', by TRT01A. */
/* The population's subjects, in each column they count in. */
data work._popc;
  set adam.adsl(where=(saffl = 'Y'));
  if trt01a in ('Placebo') then do; _col = 1; output; end;
  if trt01a in ('Placebo') then do; _col = 2; output; end;
  if trt01a in ('Xanomeline Low Dose') then do; _col = 3; output; end;
  if trt01a in ('Xanomeline Low Dose') then do; _col = 4; output; end;
  if trt01a in ('Xanomeline High Dose') then do; _col = 5; output; end;
  if trt01a in ('Xanomeline High Dose') then do; _col = 6; output; end;
  keep usubjid _col;
run;
data work._pop1; set adam.adsl(where=(saffl = 'Y')); keep usubjid trt01a; run;
proc sort data=work._pop1; by usubjid; run;
/* The records of ADLBC with strip(AVISIT) ne '.' and index(PARAMCD, '_') = 0, of the population's subjects, in each column. */
data work._stk; length usubjid $11 saffl $1 avisit $16 visit $17 param $48 paramcd $7 parcat1 $4 anrind $1 bnrind $1; set adam.adlbc(keep=usubjid saffl avisit avisitn visit param paramcd paramn parcat1 anrind bnrind) adam.adlbh(keep=usubjid saffl avisit avisitn visit param paramcd paramn parcat1 anrind bnrind); run;
proc sort data=work._stk(where=(strip(AVISIT) ne '.' and index(PARAMCD, '_') = 0)) out=work._rec; by usubjid; run;
data work._an;
  merge work._rec(in=_r) work._pop1(in=_p);
  by usubjid;
  if _r and _p;
  if trt01a in ('Placebo') and bnrind = 'N' then do; _col = 1; output; end;
  if trt01a in ('Placebo') and bnrind = 'H' then do; _col = 2; output; end;
  if trt01a in ('Xanomeline Low Dose') and bnrind = 'N' then do; _col = 3; output; end;
  if trt01a in ('Xanomeline Low Dose') and bnrind = 'H' then do; _col = 4; output; end;
  if trt01a in ('Xanomeline High Dose') and bnrind = 'N' then do; _col = 5; output; end;
  if trt01a in ('Xanomeline High Dose') and bnrind = 'H' then do; _col = 6; output; end;
run;
data work._cols; do _col = 1 to 6; output; end; run;
%ls_bign(data=work._popc, trt=_col, values=1|2|3|4|5|6|1 2|3 4|5 6, names=_lsn1 _lsn2 _lsn3 _lsn4 _lsn5 _lsn6 _bign1_2 _bign3_4 _bign5_6);

/* Subjects and records per column. */
proc sort data=work._an(keep=usubjid _col) out=work._u; by _col usubjid; run;
data work._c;
  set work._u;
  by _col usubjid;
  retain _n _e;
  if first._col then do; _n = 0; _e = 0; end;
  _e = _e + 1;
  if first.usubjid then _n = _n + 1;
  if last._col then output;
  keep _col _n _e;
run;
proc transpose data=work._c out=work._tn(drop=_name_) prefix=_n; id _col; var _n; run;
proc transpose data=work._c out=work._te(drop=_name_) prefix=_e; id _col; var _e; run;
data work._z; _z = 1; run;
data work._g1;
  merge work._z work._tn work._te;
  array _nn{6} _n1-_n6;
  array _ee{6} _e1-_e6;
  do _i = 1 to 6; _nn{_i} = sum(_nn{_i}, 0); _ee{_i} = sum(_ee{_i}, 0); end;
  _tot = sum(of _n1-_n6);
  drop _i _z;
run;
/* Per value of parcat1: subjects and records per column. */
proc sort data=work._an(keep=usubjid _col parcat1 where=(not missing(parcat1))) out=work._u; by parcat1 _col usubjid; run;
data work._c;
  set work._u;
  by parcat1 _col usubjid;
  retain _n _e;
  if first._col then do; _n = 0; _e = 0; end;
  _e = _e + 1;
  if first.usubjid then _n = _n + 1;
  if last._col then output;
  keep parcat1 _col _n _e;
run;
proc transpose data=work._c out=work._tn(drop=_name_) prefix=_n; by parcat1; id _col; var _n; run;
proc transpose data=work._c out=work._te(drop=_name_) prefix=_e; by parcat1; id _col; var _e; run;
data work._g0;
  merge work._tn work._te; by parcat1;
  array _nn{6} _n1-_n6;
  array _ee{6} _e1-_e6;
  do _i = 1 to 6; _nn{_i} = sum(_nn{_i}, 0); _ee{_i} = sum(_ee{_i}, 0); end;
  _tot = sum(of _n1-_n6);
  drop _i;
run;
proc sort data=work._g0; by  parcat1; run;
data work._g0;
  set work._g0;
  _o1 = _n_;
run;
/* [Category] of PARCAT1. */
data work._f; set work._g0; do _col = 1 to 6; output; end; run;
proc sort data=work._f; by parcat1 _col; run;
data work._k1;
  length _rowid $36 _label _pagelbl $200 _v $200;
  set work._f;
  array _nn{6} _n1-_n6;
  array _ee{6} _e1-_e6;
  _rowid = '8ce37f8d-5804-479c-8428-50933aa07917';
  _page = 1;
  _pagelbl = '';
  _k0 = 1;
  _k1 = _o1; _k2 = 0;
  _k3 = 0; _k4 = 0;
  _k5 = 0; _k6 = 0;
  _label = strip(parcat1);
  if parcat1 = 'CHEM' then _label = 'Chemistry';
  if parcat1 = 'HEM' then _label = 'Hematology';
  if parcat1 = 'HYLAW' then _label = 'Hy''s Law';
  _v = '';
  keep _rowid _label _page _pagelbl _k0 _k1 _k2 _k3 _k4 _k5 _k6 _col _v;
run;
/* Per value of parcat1 and param: subjects and records per column. */
proc sort data=work._an(keep=usubjid _col parcat1 param paramn where=(not missing(parcat1) and not missing(param))) out=work._u; by parcat1 param _col usubjid; run;
data work._c;
  set work._u;
  by parcat1 param _col usubjid;
  retain _n _e;
  if first._col then do; _n = 0; _e = 0; end;
  _e = _e + 1;
  if first.usubjid then _n = _n + 1;
  if last._col then output;
  keep parcat1 param paramn _col _n _e;
run;
proc transpose data=work._c out=work._tn(drop=_name_) prefix=_n; by parcat1 param paramn; id _col; var _n; run;
proc transpose data=work._c out=work._te(drop=_name_) prefix=_e; by parcat1 param paramn; id _col; var _e; run;
data work._g2;
  merge work._tn work._te; by parcat1 param paramn;
  array _nn{6} _n1-_n6;
  array _ee{6} _e1-_e6;
  do _i = 1 to 6; _nn{_i} = sum(_nn{_i}, 0); _ee{_i} = sum(_ee{_i}, 0); end;
  _tot = sum(of _n1-_n6);
  drop _i;
run;
proc sort data=work._g2; by parcat1 paramn param; run;
data work._g2;
  set work._g2;
  by parcat1;
  retain _r;
  if first.parcat1 then _r = 0;
  _r = _r + 1;
  _o2 = _r;
  drop _r;
run;
proc sort data=work._g2; by parcat1; run;
proc sort data=work._g0(keep=parcat1 _o1) out=work._gp; by parcat1; run;
data work._g2; merge work._g2(in=_in) work._gp; by parcat1; if _in; run;
/* [Parameter] of PARAM. */
data work._f; set work._g2; do _col = 1 to 6; output; end; run;
proc sort data=work._f; by parcat1 param _col; run;
data work._k2;
  length _rowid $36 _label _pagelbl $200 _v $200;
  set work._f;
  array _nn{6} _n1-_n6;
  array _ee{6} _e1-_e6;
  _rowid = '5dc3c63d-d230-4269-aad6-f7543bccdc31';
  _page = 1;
  _pagelbl = '';
  _k0 = 1;
  _k1 = _o1; _k2 = 2;
  _k3 = _o2; _k4 = 0;
  _k5 = 0; _k6 = 0;
  _label = strip(param);
  _v = '';
  keep _rowid _label _page _pagelbl _k0 _k1 _k2 _k3 _k4 _k5 _k6 _col _v;
run;
/* Per value of parcat1 and param and avisit: subjects and records per column. */
proc sort data=work._an(keep=usubjid _col parcat1 param avisit avisitn where=(not missing(parcat1) and not missing(param) and not missing(avisit))) out=work._u; by parcat1 param avisit _col usubjid; run;
data work._c;
  set work._u;
  by parcat1 param avisit _col usubjid;
  retain _n _e;
  if first._col then do; _n = 0; _e = 0; end;
  _e = _e + 1;
  if first.usubjid then _n = _n + 1;
  if last._col then output;
  keep parcat1 param avisit avisitn _col _n _e;
run;
proc transpose data=work._c out=work._tn(drop=_name_) prefix=_n; by parcat1 param avisit avisitn; id _col; var _n; run;
proc transpose data=work._c out=work._te(drop=_name_) prefix=_e; by parcat1 param avisit avisitn; id _col; var _e; run;
data work._g3;
  merge work._tn work._te; by parcat1 param avisit avisitn;
  array _nn{6} _n1-_n6;
  array _ee{6} _e1-_e6;
  do _i = 1 to 6; _nn{_i} = sum(_nn{_i}, 0); _ee{_i} = sum(_ee{_i}, 0); end;
  _tot = sum(of _n1-_n6);
  drop _i;
run;
proc sort data=work._g3; by parcat1 param avisitn avisit; run;
data work._g3;
  set work._g3;
  by parcat1 param;
  retain _r;
  if first.param then _r = 0;
  _r = _r + 1;
  _o3 = _r;
  drop _r;
run;
proc sort data=work._g3; by parcat1 param; run;
proc sort data=work._g2(keep=parcat1 param _o1 _o2) out=work._gp; by parcat1 param; run;
data work._g3; merge work._g3(in=_in) work._gp; by parcat1 param; if _in; run;
/* [Visit] of AVISIT. */
data work._f; set work._g3; do _col = 1 to 6; output; end; run;
proc sort data=work._f; by parcat1 param avisit _col; run;
data work._k3;
  length _rowid $36 _label _pagelbl $200 _v $200;
  set work._f;
  array _nn{6} _n1-_n6;
  array _ee{6} _e1-_e6;
  _rowid = 'b2c89fb4-7afb-42e3-bde7-00ac49bceb99';
  _page = 1;
  _pagelbl = '';
  _k0 = 1;
  _k1 = _o1; _k2 = 2;
  _k3 = _o2; _k4 = 3;
  _k5 = _o3; _k6 = 0;
  _label = strip(avisit);
  _v = '';
  keep _rowid _label _page _pagelbl _k0 _k1 _k2 _k3 _k4 _k5 _k6 _col _v;
run;
/* n: any. */
data work._f; set work._g3; do _col = 1 to 6; output; end; run;
proc sort data=work._f; by parcat1 param avisit _col; run;
data work._k4;
  length _rowid $36 _label _pagelbl $200 _v $200;
  set work._f;
  array _nn{6} _n1-_n6;
  array _ee{6} _e1-_e6;
  _rowid = '67a6ff4e-c408-4077-b930-19b20737cb95';
  _page = 1;
  _pagelbl = '';
  _k0 = 1;
  _k1 = _o1; _k2 = 2;
  _k3 = _o2; _k4 = 3;
  _k5 = _o3; _k6 = 4;
  _label = '';
  _v = strip(ifc(missing(_nn{_col}), '-', %ls_num(_nn{_col}, 0)));
  keep _rowid _label _page _pagelbl _k0 _k1 _k2 _k3 _k4 _k5 _k6 _col _v;
run;
/* Normal: npct of ANRIND = N. */
data work._f; set work._g3; do _col = 1 to 6; output; end; run;
proc sort data=work._f; by parcat1 param avisit _col; run;
proc sort data=work._an(keep=usubjid parcat1 param avisit _col anrind where=(anrind = 'N')) out=work._v; by parcat1 param avisit _col usubjid; run;
data work._v;
  set work._v;
  by parcat1 param avisit _col usubjid;
  retain _vn _ve;
  if first._col then do; _vn = 0; _ve = 0; end;
  _ve = _ve + 1;
  if first.usubjid then _vn = _vn + 1;
  if last._col then output;
  keep parcat1 param avisit _col _vn _ve;
run;
proc sort data=work._an(keep=usubjid parcat1 param avisit _col anrind where=(not missing(anrind))) out=work._d; by parcat1 param avisit _col usubjid; run;
data work._d;
  set work._d;
  by parcat1 param avisit _col usubjid;
  retain _dn _de;
  if first._col then do; _dn = 0; _de = 0; end;
  _de = _de + 1;
  if first.usubjid then _dn = _dn + 1;
  if last._col then output;
  keep parcat1 param avisit _col _dn _de;
run;
data work._k5;
  length _rowid $36 _label _pagelbl $200 _v $200;
  merge work._f(in=_in) work._v work._d;
  by parcat1 param avisit _col;
  if _in;
  array _nn{6} _n1-_n6;
  array _ee{6} _e1-_e6;
  _rowid = '9412188f-b16e-4e64-9f5c-2073fc87a708';
  _page = 1;
  _pagelbl = '';
  _k0 = 1;
  _k1 = _o1; _k2 = 2;
  _k3 = _o2; _k4 = 3;
  _k5 = _o3; _k6 = 5;
  _label = '';
  _v = strip(ifc(missing(sum(_vn, 0)), '-', %ls_num(sum(_vn, 0), 0))) || '(' || strip(ifc(missing(ifn(_nn{_col} > 0, 100 * sum(_vn, 0) / max(_nn{_col}, 1), .)), '-', %ls_num(ifn(_nn{_col} > 0, 100 * sum(_vn, 0) / max(_nn{_col}, 1), .), 0))) || '%)';
  keep _rowid _label _page _pagelbl _k0 _k1 _k2 _k3 _k4 _k5 _k6 _col _v;
run;
/* High: npct of ANRIND = H. */
data work._f; set work._g3; do _col = 1 to 6; output; end; run;
proc sort data=work._f; by parcat1 param avisit _col; run;
proc sort data=work._an(keep=usubjid parcat1 param avisit _col anrind where=(anrind = 'H')) out=work._v; by parcat1 param avisit _col usubjid; run;
data work._v;
  set work._v;
  by parcat1 param avisit _col usubjid;
  retain _vn _ve;
  if first._col then do; _vn = 0; _ve = 0; end;
  _ve = _ve + 1;
  if first.usubjid then _vn = _vn + 1;
  if last._col then output;
  keep parcat1 param avisit _col _vn _ve;
run;
proc sort data=work._an(keep=usubjid parcat1 param avisit _col anrind where=(not missing(anrind))) out=work._d; by parcat1 param avisit _col usubjid; run;
data work._d;
  set work._d;
  by parcat1 param avisit _col usubjid;
  retain _dn _de;
  if first._col then do; _dn = 0; _de = 0; end;
  _de = _de + 1;
  if first.usubjid then _dn = _dn + 1;
  if last._col then output;
  keep parcat1 param avisit _col _dn _de;
run;
data work._k6;
  length _rowid $36 _label _pagelbl $200 _v $200;
  merge work._f(in=_in) work._v work._d;
  by parcat1 param avisit _col;
  if _in;
  array _nn{6} _n1-_n6;
  array _ee{6} _e1-_e6;
  _rowid = 'ae6f2cb6-a1aa-472a-8ab4-795b101fc560';
  _page = 1;
  _pagelbl = '';
  _k0 = 1;
  _k1 = _o1; _k2 = 2;
  _k3 = _o2; _k4 = 3;
  _k5 = _o3; _k6 = 6;
  _label = '';
  _v = strip(ifc(missing(sum(_vn, 0)), '-', %ls_num(sum(_vn, 0), 0))) || '(' || strip(ifc(missing(ifn(_nn{_col} > 0, 100 * sum(_vn, 0) / max(_nn{_col}, 1), .)), '-', %ls_num(ifn(_nn{_col} > 0, 100 * sum(_vn, 0) / max(_nn{_col}, 1), .), 0))) || '%)';
  keep _rowid _label _page _pagelbl _k0 _k1 _k2 _k3 _k4 _k5 _k6 _col _v;
run;

data work._cells; set work._k1 work._k2 work._k3 work._k4 work._k5 work._k6; run;
proc sort data=work._cells; by _page _pagelbl _k0 _k1 _k2 _k3 _k4 _k5 _k6 _rowid _label _col; run;
proc transpose data=work._cells out=work._wide(drop=_name_) prefix=col;
  by _page _pagelbl _k0 _k1 _k2 _k3 _k4 _k5 _k6 _rowid _label;
  id _col;
  var _v;
run;
proc sort data=work._wide; by _rowid; run;
proc sort data=work._shell(drop=_page _pagelbl) out=work._rows; by _rowid; run;
data work._inst;
  merge work._wide(in=_w) work._rows(in=_s);
  by _rowid;
  if _w and _s;
  if _label ne '' then rowlabel = _label;
run;
data work._fixed;
  set work._shell;
  if _rowid not in ('8ce37f8d-5804-479c-8428-50933aa07917' '5dc3c63d-d230-4269-aad6-f7543bccdc31' 'b2c89fb4-7afb-42e3-bde7-00ac49bceb99' '67a6ff4e-c408-4077-b930-19b20737cb95' '9412188f-b16e-4e64-9f5c-2073fc87a708' 'ae6f2cb6-a1aa-472a-8ab4-795b101fc560');
  _k0 = _ord; _k1 = 0; _k2 = 0; _k3 = 0; _k4 = 0; _k5 = 0; _k6 = 0;
run;
data work.final;
  length col1 col2 col3 col4 col5 col6 $200 _pagelbl $200;
  set work._inst work._fixed;
run;
proc sort data=work.final; by _page _k0 _k1 _k2 _k3 _k4 _k5 _k6; run;
data work.final;
  set work.final;
  _ord = _n_;
  keep _page _pagelbl _ord _indent _rowid _kind rowlabel col1 col2 col3 col4 col5 col6;
run;

/*==== 90-report ====*/
/* 90-report: from the shell; the titles, columns, headers and footnotes are not changed here. */
%ls_need(_bign1_2 _bign3_4 _bign5_6);
%ls_final_check(columns=_page _pagelbl _ord _indent _rowid _kind rowlabel col1 col2 col3 col4 col5 col6);
proc sort data=work.final out=work._report; by _page _ord; run;
data work._report;
  set work._report;
  /* Two spaces per step of indentation: the label column keeps leading spaces (asis=on). */
  if _indent > 0 then rowlabel = repeat(' ', 2 * _indent - 1) || rowlabel;
run;
%let _lspaged = 0;
proc sql noprint; select count(*) into :_lspaged trimmed from work._report where _pagelbl ne ''; quit;

options orientation=landscape;
ods listing close;
ods rtf file="/work/out/t-14-6-04.rtf" style=journal;
title1 j=l "CDISCPILOT01" j=r "Page ~{thispage} of ~{lastpage}";
title2 j=c "Table 14-6.04";
title3 j=c "Shifts of Laboratory Values During Treatment, Categorized Based on Threshold Ranges, by Visit";
title4 j=c "Safety Analysis Set";
footnote1 j=l "NOTES: Only subjects with baseline results are included in the summary.";
footnote2 j=l "There were no subjects with abnormal low values at baseline.";
footnote3 j=l "Program: t-14-6-04.sas";
%macro _ls_report;
proc report data=work._report nowd split='|' missing style(report)={width=100%};
  column _page _pagelbl _ord _indent _kind rowlabel ("Placebo|(N=&_bign1_2.)" col1 col2) ("Xan. Low|(N=&_bign3_4.)" col3 col4) ("Xan. High|(N=&_bign5_6.)" col5 col6);
  define _page / order order=internal noprint;
  define _pagelbl / order noprint;
  define _ord / order order=internal noprint;
  define _indent / display noprint;
  define _kind / display noprint;
  define rowlabel / display "" style(column)={cellwidth=40% asis=on} style(header)={just=l};
  define col1 / display "Normal at|Baseline" style(column)={cellwidth=10% just=c} style(header)={just=c};
  define col2 / display "High at|Baseline" style(column)={cellwidth=10% just=c} style(header)={just=c};
  define col3 / display "Normal at|Baseline" style(column)={cellwidth=10% just=c} style(header)={just=c};
  define col4 / display "High at|Baseline" style(column)={cellwidth=10% just=c} style(header)={just=c};
  define col5 / display "Normal at|Baseline" style(column)={cellwidth=10% just=c} style(header)={just=c};
  define col6 / display "High at|Baseline" style(column)={cellwidth=10% just=c} style(header)={just=c};
  %if &_lspaged > 0 %then %do;
  compute before _pagelbl / style={just=l};
    line _pagelbl $200.;
  endcomp;
  %end;
  break after _page / page;
run;
%mend _ls_report;
%_ls_report;
ods rtf close;
ods listing;
%ls_final_export;

14-6.04

Program t-14-6-04.sas

Program `t-14-6-04.sas`