Screening and Randomization Period Sample Clauses

Screening and Randomization Period. Screening visits will be conducted within 30 days prior to study Day 1. During the Screening Phase, each potential subject will provide informed consent prior to starting any study-specific procedures. Due to the logistics and time needed for the retest of the , for those subjects that an investigator requests a retest of these samples, as described in Section 8.2, the screening period may be extended an additional 30 days for a screening period of up to 60 days total in order to allow subjects who are waiting the retest results the opportunity to meet all study entry criteria. Once a subject is considered eligible, prior to Day 1, a concomitant medication form will be completed by the site and sent to the sponsor for approval. See Section 7.4.1 for prohibited medications. Subjects who are eligible will be randomized as described in Section 7.3.3 and as shown in Table 2. A F2/F3 12 CRV431 75 mg Observation/Follow up B 6 Placeboa C 12 CRV431 225 mg D 6 Placebob *Randomized assignment; 2:1 – CRV431:Placebo a Matching Placebo for Cohort A - 75 mg dose. b Matching Placebo for Cohort C - 225 mg dose. Potential study subjects who meet all inclusion and exclusion criteria for this study, but who, for personal or administrative reasons, are not included in the study may be re-screened if more than 30 days has passed since their previous screening. For these subjects, use of results previously obtained for this study will be extended for an additional 30 days up to a total of 60 days. There are no restrictions on the number of re-screens permitted. Potential study subjects who previously screened and failed only but met all other inclusion criteria and met none of the exclusion criteria for this study may be re-screened.