Author contributions
MCD
RECRUITMENT
The trial was conceived of and designed by MCD and BSB. RVS and MCD oversaw the conduct of the trial and took lead roles in all aspects of study visits and patient care. Patient recruitment and screening was done by RVS. RAW assisted in patient recruitment. Collection of data was performed by MCD, RVS, CD, and DWZM. Data analyses were conducted by MCD and DV. The manuscript was written by RVS and MCD. All of the authors had access to the data and vouch for its completeness and accuracy and for fidelity to the protocol. All contributing authors were involved in review and final approval of the manuscript.