The periodic reviews by the DMC are based on their mandate in accordance with FDA agreement on protocol-defined study oversight.

FORBES: BioSante's Pollyannish Press Release

Of those who agreed to take part, 59% were regular mobile-phone users as defined by the study's protocol.

ECONOMIST: The Interphone study: Mobile madness | The

The DMC has recommended FIVE times that the LibiGel safety study continue as per FDA-approved protocol, with no modifications, since there are no signals or markers that would indicate that LibiGel is less than safe.

FORBES: BioSante's Pollyannish Press Release

To study friendship in the lab, many use a protocol called "Fast Friends, " which helps strangers establish "interpersonal closeness" in 45 minutes.

WSJ: Advice for Making New Friends: Share But Don't Overshare

Therefore, the Phase III LibiGel (testosterone gel) safety study will continue as per the FDA-agreed protocol, without modifications including continued enrollment of new subjects.

FORBES: BioSante's Pollyannish Press Release

Instead of resolving the core issues at the outset, study sites have been brought online as funding became available but with no clear roadmap or protocol for how they should do the work.

FORBES: What Caused A Billion Dollar Federal Study Of Child Health To Implode?