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How do you know the trial failed for under 45’s? It may appear...

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    How do you know the trial failed for under 45’s? It may appear simple but as a reminder for the rest of us,

    • ViralezeTM achieved a statistically significant reduction in SARS-CoV-2 viral load, the primary endpoint of the study, in the cohort of participants aged 45 and over (N=118, p=0.017).

    • ViralezeTM reduced viral load in the full study population including all patient age groups (N=197), although the difference vs placebo was not statistically significant.

    The p value for 45 years and over was 0.017.
    Statistical significance is generally recognised as 0.05 or lower.
    So, did the p value shoot up to 0.051 for the age group 44 and above? I don’t think so.
    How about 43 and above? Or 42? 41?
    We don’t know, so perhaps viraleze is good for 40+. Or perhaps 35+. Perhaps even 30+!
    We do know it is not approved for under 18’s
    At some point the p value reached 0.051 but it could have been when N =196. Again we don’t know. (Well, I don’t know!)
    For whatever reason, the company has identified 45+ and that still needs to be explained and charted.
 
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