supplementary appendix- page 10 In the second interim analysis, the significance level was also not reached (p=0.0055, Table 1), but the DSMB finally recommended to definitively stop the inclusions, considering first that the inclusion of the last 400 planned patients would most likely not change the results, second that it became ethically unacceptable to continue to include in the placebo group, third that the prolonged suspension of the inclusions due to the COVID-19 pandemic would probably complicate the resumption of inclusions. The trial was underpowered and i remain skeptical
Gracias doc, sin duda un artículo muy interesante y muy esperado 😊
Thank you sir.
Thankyou sir 😊
supplementary appendix- page 10
In the second interim analysis, the significance level was also not reached (p=0.0055, Table
1), but the DSMB finally recommended to definitively stop the inclusions, considering first
that the inclusion of the last 400 planned patients would most likely not change the results,
second that it became ethically unacceptable to continue to include in the placebo group,
third that the prolonged suspension of the inclusions due to the COVID-19 pandemic would
probably complicate the resumption of inclusions.
The trial was underpowered and i remain skeptical