Subjects (a) Inclusion criteria for subject selection. (b) Exclusion criteria for subject selection. (c) Criteria and procedures for subject withdrawal or discontinuation. (d) Point of enrolment. (e) Total expected duration of the clinical investigation. (f) Expected duration of each subject's participation. (g) Number of subjects required to be included in clinical investigation. (h) Estimated time needed to select this number (i.e. enrolment period). 1.6.4 Procedures Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 184 of 248 (a) Description of all the clinical investigation related procedures that subjects undergo during clinical investigation. (b) Description of those activities performed by sponsor representatives (excluding monitoring). (c) Any known or foreseeable factors that may compromise the outcome of clinical investigation or interpretation of results. The follow-up period during clinical investigation shall permit demonstration of performance over a period of time sufficient to represent a realistic test of the performance of the investigational medical device and allow any risks associated with adverse device effects over that period to be identified and assessed. The clinical investigation plan shall specifically address what medical care, if any, will be provided to the subjects after the clinical investigation has been completed. 1.6.5 Monitoring plan General outline of the monitoring plan to be followed, including access to source data and the extent of source data verification planned. 1.7 Statistical considerations With reference to 1.5 and 1.6, the description of and justification for:— (a) statistical design, method and analytical procedures; (b) sample size; (c) the level of significance and the power of the clinical investigation; (d) expected drop-out rates; (e) pass or fail criteria to be applied to the results of the clinical investigation; (f) the provision for an interim analysis, where applicable; (g) criteria for the termination of the clinical investigation on statistical grounds; (h) procedures for reporting any deviation from the original statistical plan; (i) the specification of subgroups for analysis; (j) procedures that take into account all the data; (k) the treatment of missing, unused or spurious data, including dropouts and withdrawals; Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 185 of 248 (1) the exclusion of particular information from the testing of the hypothesis, if relevant; and (m) in multicenter clinical investigations, the minimum and maximum number of subjects to be included for each center. Special reasoning and sample size(s) may apply for the early clinical investigation(s), e.g. feasibility clinical investigation(s).