(Clinical follow-up will be performed at 30 days, 6 months, and 1, 2, 3, 4, and 5 years post enrollment.) The following pharmacokinetic parameters will be evaluated: maximum concentration (Cmax), Cmax adjusted by treatment dose, time to maximum concentration (tmax), the time of the last quantifiable concentration (tlast ), half-life time ( t1/2), total area under the concentration-time curve from time 0 to tlast (AUC0-tlast), total area under the concentration-time curve from time 0 to tlast (AUC0-t∞) and total body clearance (CL). AUCs normalized by treatment dose will also be derived.