Yes

CORRECT

In terms of safety, always a primary concern, the investigator assumes that the patients can start the study drug and increase the dose of the drug at home and without any immediate monitoring by study personnel. This approach is based on anecdotal experience with the drug in clinical practice, and the decision to start with a relatively low dose. If the safety of the drug were not assured, the protocol should incorporate a greater degree of monitoring. This might include monitoring in person, or by telephone, for a period of hours after the first dose, and the first dose of any increase. Clearly, the complexity of the trial would be greatly increased if this were perceived to be needed.