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Methods
◦ What type of study design was utilized? (cohort, case-control, randomized controlled trial, observational, prospective, retrospective, etc.)
◦ In what setting was it conducted?
◦ What were the inclusion and exclusion criteria?
▪ What did the study look at?
▪ Were the patients volunteers with a particular disease state?
▪ Who was left out of the study?
▪ Does the exclusion criteria limit applicability of the results?
▪ Are the criteria clear and appropriate?
◦ What did the study participants receive?
◦ What were the groups being compared?
◦ Which was the intervention and which was the control group?
◦ Were patients randomly assigned to a group? If so, how?
◦ What were the primary, secondary or other efficacy and safety endpoints the study looked to investigate?
◦ What statistical tests/analyses were used to evaluate the results? Were they appropriate?
◦ What was the alpha/p-value, power set a prior? Was is appropriate?
◦ How many patients were needed to reach power?
◦ Is it ITT, mITT or per protocol?
These questions are based in the document attached.

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