15. Reduced pulmonary function, defined as < 60% of predicted value (Forced expiratory volume in one second [FEV1] divided by forced vital capacity [FVC]) or Subject has moderately severe or worse ventilatory limitation defined as < 60% of predicted value of the forced vital capacity [FVC] for age, race, sex and height (with height determined by arm span in patients with scoliosis and reference equations derived from the data of Wang et al 199329.)