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The FDA states that Receiving and incorporating FDA feedback on various elements of a future IDE submission, such as the proposed study design or statistical analysis plan, can facilitate the IDE review process and reduce the number of review cycles needed to reach full IDE approval.
The Company is presently preparing for a lock of the data, after which it will be analyzed in accordance with the study's statistical analysis plan.
The statistical analysis plan requires approximately 150 patients to be randomized into the PCOS study.
The statistical analysis plan, design of the study, capture of confounders, number and type of outcome measures, and statistical software will dictate how your data should be entered.
Among the topics are the drug development process and regulation of clinical trials, sample size considerations in clinical trials pre-market approval, the statistical analysis plan, bioequivalence clinical trials, clinical trials in the treatment of Alzheimer's Disease based on enrichment designs, pivotal proof-of-efficacy clinical trials in treating panic disorder, and monitoring clinical trials for adverse events.
o Medical review and input of protocol design and feasibility, statistical analysis plans, investigator brochure, case report form and informed consents
The study protocol and statistical analysis plan were published prior to unblinding treatment assignment.
Following identification of an error in the application of the agreed statistical analysis plan, a reanalysis of the data was undertaken.