4. Alanine transferase (ALT) or aspartate transferase (AST) > 3 x ULN. If ALT and/or AST levels are greater than 3 x ULN, the participant will return for a repeat blood draw at their earliest convenience. If the participant's ALT and/or AST is found elevated at this repeat analysis, they will be withdrawn from the study. Any elevation in ALT and/or AST will be treated per the safety guidelines outlined in section B5.