Reference no: EM133853336
Problem
For this scenario, the virus is Disease X. This virus is a previously unknown strain of influenza, with symptoms that resemble the typical seasonal flu lasting 20 (+/-1) days. There are approximately 15% risk death; however, vascular complications are frequent, resulting in 8% of patients requiring amputation of at least 1 finger or toe, and 23% increased risk of heart attacks and strokes. There are currently no approved treatments, though it is known that standard flu treatments are ineffective.
A. State the study objective.
B. State the study design (prospective or retrospective, phase, randomized - nonrandomized; open - blind; multicentric national or global, safety and/or efficacy).
C. What would be your study population (treatment naïve patients, a specific time from diagnosis, based on the severity of the disease etc)? List two inclusion and two exclusion criteria. If no inclusion/exclusion provide an explanation. Get the instant assignment help.
D. State at least two study endpoints, and the tools to measure them. State the tests that will be used for statistical analysis and why those are appropriate for this type of study.
E. Calculate an estimated sample size for the study. If you must; use power as 80% and ? as 0.05.
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