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Fig. 2 NNT for ≥ 50%% max TOTPAR compared with placebo over six hours post dose.
Tertiary endpoints included an assessment of SAEs up to 19 months post Dose 1.
These symptoms usually appeared 2 12 hours after injection and disappeared 24 hours post dose.
Maximum post dose changes (Emax) were used as the primary outcome measures.
Anti-CS antibody GMTs were significantly greater with RTS,S/AS01B compared to RTS,S/AS02A 1 month post Dose 2 (Day 60, p≤0.001), 1 month post Dose 3 (Day 90, p≤0.001), 4½ months post Dose 3 (Month 6½; p = 0.003) and 10 months post Dose 3 (Month 12; p = 0.002).
Hours post dose were recorded.
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Drug efficacy was evaluated in patients 2 h post-dose.
Figure 1 Experimental statistical power at day 7 post-dose.
Plasma samples were withdrawn until 48 h post-dose.
Lag times in absorption ranged from 0 to 4 h post-dose.
Total pain relief (TOTPAR), calculated as the sum of every post-dose assessment.
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