Table 6.

Reasons for Withdraw, Randomized Subjects.

Reason for Withdrawal	D-tagatose 2.5g N = 57 n (%)	D-tagatose 5.0g N = 51 n (%)	D-tagatose 7.5g N = 53 n (%)	Total N = 161 n (%)
Subject Request	3 (5.3%)	5 (9.8%)	10 (18.9%)	18 (11.2%)
Lost to Follow-up	3 (5.3%)	3 (5.9%)	5 (9.4%)	11 (6.8%)
AE/SAE	5 (8.8%)	2 (3.9%)	1 (1.9%)	8 (5.0%)
Protocol Deviation	3 (5.3%)	2 (3.9%)*	2 (3.8%)	7 (4.3%)
Termination by Sponsor	2 (3.5%)	0 (0.0%)	0 (0.0%)	2 (1.2%)
Other	6 (10.5%)†	7 (13.7%)	1 (1.9%)	14 (8.7%)
Total Withdrawn	22 (38.6%)	19 (37.3%)	19 (35.8%)	60 (37.3%)

N = Randomized subjects; denominator for all percentages

^*One randomized subject in this dose group had a recorded reason for withdrawal of “screen failure” and was therefore tabulated with those withdrawn for a protocol deviation

^†One randomized subject in this dose group had no reason for withdrawal specified on the CRF and was therefore tabulated with “Other”