 If necessary for patient safety, unscheduled visits may be arranged. Unscheduled source document sets used for visits attended between routine patient visits will be labeled with the last attended visit number followed by a decimal point and the number of the unscheduled visit i.e. if two unscheduled visits are attended between Week 0 and Week 1 then those unscheduled visits would be labeled as unscheduled visit sets 0.1 and 0.2 in chronological order. 