General Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India. (a) Description of the type of clinical investigation to be performed (e.g. comparative double-blind, parallel design, with or without a comparator group) with rationale for the choice. (b) Description of the measures to be taken to minimize or avoid bias, including randomization and blinding or masking. (c) Primary and secondary endpoints, with rationale for their selection and measurement. (d) Methods and timing for assessing, recording, and analyzing variables. (e) Equipment to be used for assessing the clinical investigation variables and arrangements for monitoring maintenance and calibration. (f) Any procedures for replacement of subjects. 1.6.2 Investigational medical device and comparator (a) Description of the exposure to the investigational medical device or comparator, if used. (b) Justification of the choice of comparator. (c) List of any other medical device or medication to be used during clinical investigation. (d) Number of investigational medical devices to be used, together with a justification.