 Subjects who do not meet eligibility criteria during the initial screening attempt will be permitted to rescreen 2 times, for a total of 3 screening attempts. Rescreen subjects must first be registered as screen failed in the CTMS system and subsequently registered as a rescreen subject. Once the subject is registered as rescreened, all screening procedures will need to be repeated.;The exact time interval of each re-screen would be at the discretion of the investigator. Completion of rescreen would be no greater than 6 months from the initial screening date. 