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July 6, 2005

Methodological Standards in Human vs Animal Clinical Trials—Reply

Author Affiliations

Letters Section Editor: Robert M. Golub, MD, Senior Editor.

JAMA. 2005;294(1):40-41. doi:10.1001/jama.294.1.40-b

In Reply: In our study, following cerebral arteriography and clot placement, all monkeys were randomized to control (n = 8) or nitrite (n = 6) groups. However, after the first day of infusion in 3 monkeys from the nitrite group, we noticed that there was no change in blood pressure and that blood methemoglobin levels remained significantly below toxicity levels. We therefore increased the nitrite dose in each of these first 3 monkeys (via delivery of boluses) and also increased the dose for the subsequent 3 monkeys in the nitrite group. Thus, all monkeys were randomized to the different treatment modalities.

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