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  Vol. 294 No. 1, July 6, 2005 TABLE OF CONTENTS
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Methodological Standards in Human vs Animal Clinical Trials—Reply

Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

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.

In our research on vasospasm after subarachnoid hemorrhage, we have been aware of the possible biases that affect both preclinical and clinical trials. In our current study, saline and nitrite were infused continuously in conscious primates over 14 days, using identical fluid volumes, pumps, catheters, and jackets. Treatment was not blinded because toxicity . . . [Full Text of this Article]

Ryszard M. Pluta, MD, PhD
rysiek@ninds.nih.gov
Surgical Neurology Branch
National Institute of Neurological Disorders and Stroke

Mark T. Gladwin, MD
Critical Care Medicine Department
Laboratory of Chemical Biology
National Institute of Diabetes and Digestive and Kidney Diseases

Edward H. Oldfield, MD
Surgical Neurology Branch
National Institute of Neurological Disorders and Stroke
National Institutes of Health
Bethesda, Md



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Methodological Standards in Human vs Animal Clinical Trials
Kennon Heard, Vikhyat S. Bebarta, and Steven R. Lowenstein
JAMA. 2005;294(1):40.
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Nitrite Infusions to Prevent Delayed Cerebral Vasospasm in a Primate Model of Subarachnoid Hemorrhage
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JAMA. 2005;293(12):1477-1484.
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