6.2 Background Information

6.2.1 Name and description of the investigational product(s).

6.2.2 A summary of findings from nonclinical studies that potentially have clinical significance and from clinical trials that are relevant to the trial.

6.2.3 Summary of the known and potential risks and benefits, if any, to human subjects.

6.2.4 Description of and justification for the route of administration, dosage, dosage regimen, and treatment period(s).

6.2.5 A statement that the trial will be conducted in compliance with the protocol, GCP and the applicable regulatory requirement(s).

6.2.6 Description of the population to be studied.

6.2.7 References to literature and data that are relevant to the trial, and that provide background for the trial.