2.2. Randomization, Allocation Concealment, and Blinding
A randomization list was generated using software (randomization.com) at a 1-to-1 ratio, with participants allocated in blocks of six, and the randomization sequence was created by an independent researcher outside the clinic. The sequence was stored in opaque sealed envelopes which were kept outside the clinical center for blinding purposes.Participants and the research team were not blinded to the intervention and control groups. However, the assessment of outcomes was conducted by an independent blinded researcher.Between November 2015 and October 2017, we screened 460 participants. Out of these, 160 did not meet the eligibility criteria, and 180 declined to participate. A total of 120 participants were randomized to the intervention and control groups. By April 2018, 15 and 10 participants were lost to follow-up in the intervention and control groups, respectively. 