definiens: means a human clinical study conducted [ * * ] that is designed to demonstrate the [ * * ] generated in a study of [ * * ] treated with the Licensed Product to [ * * ] 3 of the Licensed Product in [ * * ] . Data to evaluate in such a study might include pharmacokinetics, efficacy and/or additionalsafety data . The Bridging Clinical Study shall be designed such that, if its endpoints are met, [ * * ], and to allow [COMPANY] Hakko [ * * ] in seeking Regulatory Approval for the Licensed Product in Japan . It is expected that a Bridging Clinical Study shallrequire the enrollment of no more than [ * * ] patients for the NDA submission in Japan . For purposes of clarity, if the ClinicalStudies required by the Japanese Regulatory Authorities require more than [ * * ] patients in total, those Clinical Studies shallbe [ * * ] and if the Clinical Studies required by the Japanese Regulatory Authorities require fewer than [ * * ] patients in total, those Clinical Studies shall be [ * * ]