definiens: means : EXHIBITF TPPSTUDIES Required Outcome Comparator Superior to EC - naproxen Superior to EC - naproxen Not Celebrex inferior to 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 1 . Western Ontario and McMaster Universities ( WOMAC ) Osteoarthritis Index Pain Subscale 2 . WOMAC Function Subscale 3 . Patient Global Assessment of OA ( PGA ) visual analogue scale ( i ) for TPP 1, completion of 2 adequate and well controlled studies having results that ( x ) achieve the Required Outcome ( as defined above ) for the TPP I Endpoint ( as defined above ) with a p<0.05 and ( y ) are sufficient for inclusion in the label based on then - current FDA practices and/or guidelines ; ( ii ) for TPP 2, completion of 2 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<0.05 and ( y ) are sufficient for promotion, based on then - current FDA or DDMAD practices and/or guidelines ; ( iii ) for TPP 3, completion of 2 adequate and well controlled studies having results that achieve the Required Outcome ( as defined above ) for the TPP 3 Endpoint ( as defined above ) when the upper limit of 95 % confidence interval between PN400 and Celebrex is less than or equal to a pre - specified, mutually agreed, non­inferiority margin that supports a conclusionary statement in the label, and Diligent Efforts to secure a conclusionary statement in label