Reffering to US FDA clinical trial phase 2 protcol for patiets with majr depresive disorder, please describ this protcol designs elments that wil mitigaate rissk of this treatment to patieeents.

Aare thre any certaain incluson or excluson critria that wil ensur thast patiennts whoo mighgtt be att rissk for treeatment toxcitis of studdy drugg r not inclludded? Whaat r theey?

Aare theere speecificc instructon to invesstigatr to maange potntial treatmemnt-relateed toxxicities? Whaatt aree theey?

Based on above reference protcol ,Provide asessmnet for clincal trial phas 2 study protcol of an investigatinal antidepresant in patiets with majr depresive disorder that are the incluson & excluson critria & protcol instruuctioms to mange potrntial treatmnet-related toxicites suficient? If soo, whyy? Iff not,, whyy not?areee anny mising orr are anny inapropriate?

Pleaseeeee provide answeeer in DETAIL with detailed explanation.