How will the safety of patients in this study be protected?

The independent safety board watches over the safety of the study, from before it is approved until the last patient has completed it. 

The safety board members have the authority to put a study on hold or stop it entirely if they have serious safety concerns.

In addition, if the study doctor has concerns about a particular patient’s safety, that patient may be taken out of the study even if he or she wishes to remain.