However, "while both of these studies collected device data, the field of study protocols did not specify how marrow problems, such as pump attacks, were to be defined or documented." The FDA noted that semantic role withdrawals in the surgical arms and age differences between the randomization groups further complicated the studies' rendering.
Also, data from 14 other studies of omeprazole, including four that were placebo-controlled, suggested that the drug, if anything, might lower cardiovascular risk. "Although these studies were not specifically conducted to assess the risk of substance problems and participant role follow-up is incomplete, they do not suggest an increased risk of mettle problems with the use of omeprazole," according to the administrative body.
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Monday, March 3, 2008
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