definiens: means : TPP Endpointt Cumulative incidence of gastric ulcers over 6 months compared to EC - naproxen alone General GI symptomology ( upper GI AEs and/or patient reported outcomes ) compared to EC - naproxen alone WOMAC study Non - inferiority design to demonstrate PN400 is not inferior to Celebrex in arthritis pain and symptom control ( i ) for TPP 1, completion of2 adequate and well controlled studies having results that ( x ) achieve the Required Outcome ( as defined above ) for the TPP 1 Endpoint ( as defined above ) with a p < O.05 and ( y ) are sufficient for inclusion in the label based on then - current FDA practices and/or guidelines ; ( ii ) for TPP 2, completion of2 adequate and well controlled studies having results that ( x ) achieve the Required Outcome ( as defined above ) for the TPP 2 Endpoint ( as defined above ) with a p < O.05 and ( y ) are sufficient for promotion, based on then - current FDA or DDMAC practices and/or guidelines ; ( iii ) for TPP 3, completion of 1 adequate and well controlled study having results that achieve the Required Outcome ( as defined above ) for the TPP 3 Endpoint ( as defined above ) where the upper limit of95 % confidence interval between PN400 and Celebrex is less than or equal to a pre - specified, mutually agreed, non - inferiority margin that supports a conclusionary statement in the label, and Diligent Efforts to secure a conclusionary statement in label