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  • The exclusion from the evaluation of the vast majority of sufferers who obtained steroids implies that it is unimaginable to draw strong conclusions about their impact and underlines the need for a trial.
  • Clinical success (defined as stabilisation or enchancment at 2 weeks) was decrease within the forty one steroid recipients analysed (sixty six% versus 86%).
  • The Graybill analysis was limited to only 41 of the 150 steroid recipients, and did not report their impact on mortality.
  • Apparently worse mycologic outcomes in these forty one sufferers are impossible to interpret, as a result of no adjustments were made for the antifungal therapy obtained, fungal load, or clinical severity at baseline, all of which are recognized to be essential end result predictors .
  • Steroids were prescribed at the discretion of the attending doctor, and the reasons for prescription are unclear.
  • At these interim analyses, the DMEC will receive a report together with unblinded summaries of mortality, serious antagonistic events, grade three and four antagonistic occasions, and estimates of the speed of CSF sterilisation in the course of the first 14 days (from chosen websites solely) by treatment arm.

We will mannequin the speed of IRIS over time with a cause-particular hazards model, bearing in mind the competing risk of prior death https://cryptolisting.org/coin/cdx. CM-related IRIS might be outlined as per the current proposed definition (see Appendix 2) .

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