Randomization
Patients were randomized 1 : 1 to the intervention or control group after baseline assessments. Block randomization was used to reduce the risk of bias and to ensure balance in the allocation of patients between sites. An independent statistician created the randomization table in the eCRF. The members of the research team did not have access to the randomization module. At each site, a qualified and independent monitor oversaw the data and study process.