Table 1.

Safety Boundary Using Blinded Data.

	Number of Subjects
Number of Events	SPRT	TS
1	n.a.	n.a.
2	2	≤3
3	≤11	≤8
4	≤20	≤13
5	≤28	≤18
6	≤37	≤22
7	≤46	≤27
8	≤55	≤33
9	≤63	≤38
10	≤72	≤43