Table 2.

Subjects by visit.

		Subjects	Acceptable Fita	Unacceptable Fit
Visit	Month	(n)	(n)	(n)	(%)
1	0	195	195	n/a	n/a
2	6	195	168	27	13.8
3	12	183	164	19	10.4
4	18	173	161	12	6.9
5	24	163	143	20	12.3
6	30	154	131	23	14.9
7	36	134	113	21	15.7
	Sum: subject/visit combinations	1,197		Average Unacceptable % (Visits 2–7):	12.3%

^aAcceptable = achieved a FF ≥ 100 on a least one of 9 donnings and a 90th percentile FSL ≤ 5% for the set of nine donnings.