Studies: This section of PSUR shall capture the brief summary of clinically important emerging efficacy or effectiveness and safety findings obtained from the Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India. licence holder sponsored clinical investigation and published safety studies that became available during the reporting interval which has the potential impact the product safety information. (i) Summaries of Significant Safety Findings from Clinical investigation during the reporting period (ii) Findings from Non-interventional Studies (iii) Findings from Non-Clinical Studies (iv) Findings from Literature.