A guideline for clinical studies of antibacterial drugs aimed to conduct for marketing approval has been provided through the PMSB/ELD Notification of “Guideline for Clinical Evaluation of Antibacterial Drugs” (Notification No. 743 by the Director of Evaluation and Licensing Division, Pharmaceutical and Medical Safety Bureau, MHW, dated August 25, 1998, hereinafter referred to as “Former GL Notification”)