Results of the clinical investigation covering, with rationale and justification, subject demographics, analysis of results related to chosen endpoints, details of subgroup analysis, as well as compliance with the CIP, and covering follow-up of missing data and of patients withdrawing from the clinical investigation, or lost to follow-up.
Torthaí an imscrúdaithe chliniciúil lena gcumhdófar, le réasúnaíocht agus bonn cirt, déimeagrafaic na n-ábhar don imscrúdú, anailís ar na torthaí a bhaineann leis na críochphointí a roghnaíodh, mionsonraí anailís an fhoghrúpa, chomh maith le comhlíonadh an PIC, agus lena gcumhdófar obair leantach maidir le sonraí atá ar iarraidh agus maidir le hothair a tharraing amach as an imscrúdú nó nár cuireadh san áireamh san obair leantach.