definiens: means a human clinical trial of a Product on a sufficient number of subjects that is designed to:(a ) gather the additional information about effectiveness and safety of such Product in the indication being studied needed toevaluate the overall benefit - risk relationship of such Product and to provide adequate basis for physician labeling ; ( b ) define A-9 [ * * * * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filedseparately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, asamended.warnings, precautions and adverse reactions that are associated with such Product in the dosage range to be prescribed ; and(c ) support regulatory approval of such Product for the treatment in such indication, as described in 21 C.F.R. § 312.21(c ), or asimilar clinical study prescribed by the applicable regulatory authorities in a country other than the United States ; [ * * * * ]