Solved: Exercises 45 through 48 refer to a clinical trial named APPROVe designed to

Chapter 14, Problem 47

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Exercises 45 through 48 refer to a clinical trial named APPROVe designed to determine whether Vioxx, a medication used for arthritis and acute pain, was effective in preventing the recurrence of colorectal polyps in patients with a history of colorectal adenomas. APPROVe was conducted between 2002 and 2003 and involved 2586 participants, all of whom had a history of colorectal adenomas. The participants were randomly divided into two groups: 1287 were given 25 milligrams of Vioxx daily for the duration of the clinical trial (originally intended to last three years), and 1299 patients were given a placebo. Neither the participants nor the doctors involved in the clinical trial knew who was in which group. During the trial, 72 of the participants had cardiovascular events (mostly heart attacks or strokes). Later it was found that 46 of these people were from the group taking the Vioxx and only 26 were from the group taking the placebo. Based on these results, the clinical trial was stopped in 2003 and Vioxx was taken off the market in 2004.(a) Describe the control and treatment groups inAPPROVe.