Subjects not continuing in the 1 2 0 2 5 study (%) (8.3) Reason for not continuing in the study (%) Adverse event 0 1 0 0 1 (8.3) (2.1) Lost to follow-up 0 1 0 1 2 (8.3) (9.1) (4.3) Poor/non-compliance 0 0 0 1 1 (9.1) (2.1) Subject request to discontinue 1 0 0 0 1 study treatment (8.3) (2.1) 1 Subjects completing or not completing the on-treatment period; 2 Subjects who continued into or did not continue the follow-up period. Table 4B: End of treatment period Stage 2 Treated subjects – – ASV 200 mg PBO Total BD Subjects 177 61 238 Subjects completing the period 1 (%) 153 (86.4) 41 194 (67.2) (81.5) Subjects not completing the period 1 24 (13.6) 20 44 (%) (32.8) (18.5) Reason for not completing the period 1 (%) Lack of efficacy 7 (4.0) 11 18 (7.6) (18.0) Adverse event 10 (5.7) 3 (4.9) 13 (5.5) Subject withdrew consent 2 (1.1) 1 (1.6) 3 (1.3) Death 1 (0.6) 0 1 (0.4) Lost to follow-up 1(0.6) 1 (1.6) 2 (0.8)
Subjects not continuing in the study (%) 1 (8.3) 2 0 2 5 Reason for not continuing in the study (%) Adverse event 0 1 (8.3) 0 0 1 (2.1) Lost to follow-up 0 1 (8.3) 0 1 (9.1) 2 (4.3) Poor/non-compliance 0 0 0 1 (9.1) 1 (2.1) Subject request to discontinue study treatment 1 (8.3) 0 0 0 1 (2.1) 1 Subjects completing or not completing the on-treatment period; 2 Subjects who continued into or did not continue the follow-up period. Table 4B: End of treatment period – Stage 2 – Treated subjects ASV 200 mg BD PBO Total Subjects 177 61 238 Subjects completing the period 1 (%) 153 (86.4) 41 (67.2) 194 (81.5) Subjects not completing the period 1 (%) 24 (13.6) 20 (32.8) 44 (18.5) Reason for not completing the period 1 (%) Lack of efficacy 7 (4.0) 11 (18.0) 18 (7.6) Adverse event 10 (5.7) 3 (4.9) 13 (5.5) Subject withdrew consent 2 (1.1) 1 (1.6) 3 (1.3) Death 1 (0.6) 0 1 (0.4) Lost to follow-up 1(0.6) 1 (1.6) 2 (0.8)
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