29 2.1.4 Recruitment Strategies ............................................................................................ 30 2.2 Screening Evaluation ...................................................................................................... 30 2.2.1 Clinical Evaluation .................................................................................................. 30 2.2.2 Laboratory studies ................................................................................................... 30 2.3 Baseline Evaluation ........................................................................................................ 31 2.3.1 Laboratory studies ................................................................................................... 31 2.3.2 Electrocardiogram (ECG) within 28 days prior to protocol enrollment ................. 31 2.3.3 Scans and X -rays: ...................................................................................................