Explanation for the choice of comparators
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In the USA, only the FDA-approved TICE® BCG (for intravesical use) BCG LIVE strain of the BCG (Merck) vaccine or a saline placebo will be administered. This will be given intradermally (0.1 mL) in the deltoid area. Placebo vaccine will be 0.1 mL 0.9% NaCl, which is the same amount and color as the intervention.