definiens: means a human clinical study in any country condu cted to ( a ) evaluate the effectiveness of a drug for a particular indication or indications in patients with the disease or con dition under study and ( b ) determine the common short - term side effects and risks associated with the drug, which s tudy may also explore a variety of doses, dose responses 10 and duration of effect of the applicable drug . In t he United States, means a human clinical study that satisfies the requirements of 2 1 C.F.R. § 312.21(b ) and in jurisdictions outside o f the United States, a human clinical study that satisfies the r equirements of any analogous regulation . A Phase 1B clinical study will not be considered a Phase 2 Clinical Stu dy unless and until FSFD in the portion of any such Phase 1B clinical study that qualifies as a Phase 2 Clinical Study under 21 C.F.R. § 312.21(b ) or any analogous regulation in jurisdictions outside of the United States