Note: For all GLP studies the purity of the CZ48 as determined by HPLC validated methods is 98.9%. For these studies, the drug was formulated in a 0.5% medium density carboxymethyl cellulose aqueous suspension (CMC). For all non-GLP studies the drug (98% purity) was formulated as a suspension in cottonseed oil (except the non-GLP study performed by Covance which also used the CMC formulation).