On-study laboratory tests (including pregna ncy testing) to be done on site/local within 72 hours prior to dosing. Chemistry X XSee Section 9.4.4, Table 9.4.4-1 . Includes assessments for sodium, potassium, chloride, total serum calcium, m agnesium, carbon dioxide, phosphorus, BUN, creatinine, creatinine kin ase, CrCl, fasting glucose, total protein, albumin, amylase, lipase, CRP , LDH, AST, ALT, total bilirubin, direct bilirubin (reflex only), ALP , and GGT (reflex only). CBC with Differential and PlateletsXX Thyroid Function Tests X XTo include TSH with reflex testing (free T3 and free T4), if applicable. Results should be examined by the investigator or appropriate designee within 48 hours of dose administration.