(iii) a table compiling all observed device defici...

(iii) a table compiling all observed device deficiencies that could have led to a serious adverse effect, and any corrective actions taken during the clinical investigation, if any; (iv) any needed subgroup analysis for special populations (i.e. gender, racial /cultural /ethnic subgroups), as appropriate; (v) an accountability of all subjects with a description of how missing data or deviation(s) were dealt within the analysis, including subjects:— (A) not passing screening tests; (B) lost to follow-up; (C) withdrawn or discontinued from the clinical investigation and the reason. 8. Discussion and overall conclusions The conclusions may include the following points:— (a) the safety and performance results and any other endpoints; (b) an assessment of risks and benefits; (c) a discussion of the clinical relevance and importance of the results in the light of other existing data; (d) any specific benefits or special precautions required for individual subjects or groups considered to be at risk; (e) any implications for the conduct of future clinical investigations; (f) any limitations of the clinical investigation.