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Previous Volume 346:289-290 January 24, 2002 Number 4 Next

	Since this article has no abstract, we have provided an extract of the first 100 words of the full text and any section headings.

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To the Editor: On October 4, 2001, the Antiviral Drugs Advisory Committee of the Food and Drug Administration (FDA) discussed¹ the results of the clinical trial reported by Walsh and colleagues in this issue of the Journal.² The authors present the unstratified analysis in their report. The plan for the primary analysis of this trial was defined prospectively as the evaluation of the overall stratified rate of response in terms of a five-part composite end point. The stratified analysis is the appropriate primary analysis, since patients were stratified at randomization according to their degree of risk of fungal infection . . . [Full Text of this Article]

References

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