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The amount of money subjects were willing to pay to take the drug was significantly greater than that for placebo and for 2 doses of immediate-release hydrocodone life alprazolam but for neither of 2 hydrocodone codeine phosphate doses of extended-release alprazolam. The authors concluded that extended-release alprazolam has less potential for abuse than immediate-release alprazolam.
Clinical Review Methods A.How the Review was Conducted Materials described in Sections IVA and IV.B. Original data and summaries of results submitted by the hydrocodone sponsor were reviewed and compared with the results of the reviewer's analyses. Relevant statistical analyses were conducted, and hydrocodone codeine phosphate pertinent literature searches were performed. B.Overview of Materials Consulted in Review The materials described in Section IV.A. C.Overview of Methods Used to Evaluate Data Quality and Integrity The reviewer and consultants examined original data such as Case Report Forms, data sets, and phentermine no prescription online buy data collected for individual subjects during the conduct of the pivotal trial under review. Results of these examinations, as well as results of statistical analyses, were hydrocodone codeine phosphate compared with the results and summaries submitted by the sponsor. D.Were Trials Conducted in Accordance with Accepted Ethical Standards?- It appears that the trials, under review were conducted in accordance with accepted ethical standards. E.Evaluation of Financial Disclosure In Volume 1, item 19, the sponsor has provided adequate information regarding financial disclosure for clinical investigators: "As communicated to FDA in our correspondence regarding XANAX XR Tablets, dated September 27, 2001(IND 23,179, Serial #123), and confirmed in FDA's response dated November 26, 2001, Study M/2000/0369  is the only 'covered' clinical study [as defined in 21CFR 54.2(e)] for purposes of this application. However, we are providing financial disclosure for other supportive studies as well. Pharmacia buy xanax cash & Upjohn is providing Form 3454 in accordance with the FDA Guidance Document 'Financial Disclosure by Clinical Investigators,' Part II.A-C, 'Disclosable Financial Arrangements.' Certification is provided, that none of the participating investigators hydrocodone codeine phosphate entered into any financial arrangements with the sponsor of this trial (the former Upjohn Company) in regards to the following categories of financial interest: 1.Financial arrangements whereby the value of compensation would be influenced by the outcome of the protocol. 2.An equity interest in the sponsor of a covered study, i.e., any ownership interest, stock options, or financial interest whose value can be readily determined through reference to public prices. .' 3.A proprietary interest in the tested product, including, but not limited to, hydrocodone codeine phosphate a patent, trademark, copyright or licensing agreement. All other requirements for reporting such an interest regarding significant payments of other sorts or significant equity interest in the sponsor of the study (Part H.D-E of the above-mentioned guidance document) do not apply because the covered study (and the supportive studies) were completed prior to 2 February 1998." APPEARS THIS WAY ON ORIGINAL VI.
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