Information given on prompt: Sponsor, Collaborators, Location. Background and purpose, Procedure, Subjects, Inclusion Criteria and Exclusion Criteria. Discussion should include the application of the principle of beneficence and the principle of autonomy.

Information given on prompt: Sponsor, Collaborators, Location. Background and purpose, Procedure, Subjects, Inclusion Criteria and Exclusion Criteria.  Discussion should include the application of the principle of beneficence and the principle of autonomy.