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Letters |1 January 1998

Zafirlukast in Asthma

Peter K. Honig, MD; Raymond Anthracite, MD; John K. Jenkins, MD

Article, Author, and Disclosure Information
Author, Article, and Disclosure Information
  • U.S. Food and Drug Administration; Rockville, MD 20857
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TO THE EDITOR:
Suissa and colleagues' article [1] illustrates potential limitations of peer review in evaluating manuscripts submitted for publication. It also reinforces the importance of a priori designation of the primary end points and statistical methods to be used in the conduct and analysis of randomized, controlled clinical trials.
Zafirlukast was approved by the U.S. Food and Drug Administration (FDA) on 26 September 1996 for prophylaxis and long-term treatment of asthma [2]. This approval was based, in part, on the results of the large, prospective, placebo-controlled trial (study 0029) [3] that is referenced in Suissa and colleagues' article...
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Honig PK, Anthracite R, Jenkins JK. Zafirlukast in Asthma. Ann Intern Med. 1998;128:70. doi: 10.7326/0003-4819-128-1-199801010-00013

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Published: Ann Intern Med. 1998;128(1):70.

DOI: 10.7326/0003-4819-128-1-199801010-00013

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