Randomization and blinding
Participants, laboratory staff, data collectors, outcome assessors were blinded by not informing them of the group allocations. Data analysts were blinded by providing them with a blinded version of the data. The principal Investigator was aware of treatment assignments. Random sequence of participants was made using Blocked randomization (blocks of 4) by Microsoft Excel, using the RAND function. Sequentially numbered, opaque, sealed envelopes were used to conceal the allocation sequence from the researchers who were enrolling and assessing the participants. Outcome assessment was done by the same assessor for two groups.