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Venkatachalam, G

Animal care complied with SOPs of the Pharmacology Animal Facility and the European Convention for the Protection of Vertebrate Animals used for Experimental and Other Scientific Purposes (ETS 123)

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Handling best practices Minimize the time reconstituted vials spend out of refrigeration Never touch the rubber stopper with anything except an alcohol-swabbed needle Draw doses quickly and return vial to refrigerator immediately Use a fresh needle for each vial entry to minimize contamination risk Never share vials between users Contamination is a significant risk with multi-dose vials

Ensure sterile preparation, start with small test areas, and avoid application to actively infected or weeping lesions

The regimen would be declared promising in cohort 1 if 27 patients present a confirmed objective response among 67 and in cohort 2 if 13 confirmed objective responses were observed among 40