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Summary
A study was carried out in general practice to assess the benefit-risk ratio of a single new drug, bromazepam, prior to marketing. Analysis of data supplied by 393 participating doctors on 3101 patients showed that bromazepam, in a dose range of 3 mg to 9 mg daily in divided doses, was effective as an anxiolytic in 79% of the patients and that the acute risk of treatment was predictable and low. It is concluded that the acute benefit-risk ratio is acceptable with respect to the class of drug and indication for which bromazepam is prescribed.