Groups of primary stakeholders are formed in order to participate in discussion and analysis.

C.C.K. participated in analysis of data and manuscript editing.

VEP participated in the design of the study, analysis of results, and writing of the manuscript.

Authors' contributions DJ participated in the design, data collection, analysis, and drafting of the manuscript.

KK participated in the study design, analysis of data, and revision of the manuscript.

KA participated in data collection and statistical analysis.

Author 8 (MBT) participated in statistical analysis and interpretation of the data.

Author 9 (MM) participated in histologic diagnosis and immuno-histochemical analysis.

RJM participated in study design, statistical analysis and manuscript preparation.

Dr. Carter will participate in analysis of the samples.