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.