Table 3.

Results

Time	Phase 1	Phase 3	P value
Mean administration time (min) [STD]	73.6 [34.1]	33.2 [14.2]	<.0001
Median administration time (min) [25–75% IQR]	70.0 [55.0–95.0]	30.0 [24.3–38.8]
Pre reconstitution median time (min) [25–75% IQR]	25.5 [12.8–34.5]	xxx
Post reconstitution median time (min) [25–75% IQR]	43.5 [31.0–60.0]	xxx
Time	Phase 3 conform (82%)	Phase 3 Non-conform (18%)	P value
Mean administration time (min) [STD]	28 [7.8]	56.9 [12.8]	0.0002
Median administration time (min) [25–75% IQR]	28.0 [24.0–33.5]	58.0 [56.5–65.0]
Pre reconstitution median time (min) [25–75% IQR]	0 [0–0]	xxx
Post reconstitution median time (min) [25–75% IQR]	28.0 [24.0–33.5]	xxx