An IND (Investigational New Drug) Application Must Contain Which of the Following

An IND (Investigational New Drug) application must contain which of the following information?
I. Pharmacological and toxicological studies in animal models
II. Information concerning the manufacture of a new drug
III. Information concerning proposed drug protocols
IV. Phase II clinical trial data

A) I and II only
B) I and IV only
C) I, II, and III only
D) III only