Screening Overview Sample Clauses

Screening Overview. Screening Visit 1 will start a variable length screening period. The length of the screening period is to be no shorter than 7 days, but may be as long as 35 days in order to accommodate medication taper and discontinuation or other study requirements. If the patient is eligible to continue in the study, and does not need to discontinue any excluded medication, the patient may be scheduled to return for Visit 2 (Randomization) in 7 (or more) days, assuming all screening evaluations have been completed, including confirmation of acceptable laboratory and ECG results. If the patient needs to undergo taper and discontinuation of excluded medication, the Investigator will generate a written down titration schedule for the patient and will schedule Visit 2 such that the date of Visit 2 is at least 1 week after the date of the final dose of any excluded medication. If additional clinic visits are deemed necessary by the investigator for clinical monitoring of the patient before scheduling Visit 2, such visits will be recorded as unscheduled visits.