definiens: means a human clinical trial for any Product in the United States that would satisfy therequirements of 21 CFR 312.21(a ), ( b ) or ( c ), or in any other country would satisfy the requirements ofsimilar regulations applicable in that country, including a Phase I Clinical Trial, Phase II Clinical Trial orPhase III Clinical Trial, with a having the principal purpose of preliminarydetermination of safety in healthy volunteers or patients with the aim of establishing the dosageregimen, pharmacokinetic, pharmacodynamic and early safety profile and the suitability of a product forfurther clinical trials, a having the primary purpose of determination of a firstindication of efficacy in patients being studied and expanding the Phase I experience ; and a being a pivotal, multi - centre, human clinical trial that is prospectively designed todemonstrate statistically whether a product is safe and effective for use in humans in the Indicationbeing investigated