Date

2026-08-07

Protocol

No protocol changes

Item Changed

Intervention(s) planned (typographical error)

Previous Version

2.Randomization a) Minimisation method, which is a type of covariate adaptive randomization, will be utilized to allocate the participants to intervention and control groups. Age and sex will be the covariates considered. The first participant will be randomly assigned to either the treatment or control group. Each subsequent participant will be assigned to study groups (intervention and control) using a minimisation method to ensure balance in age and sex covariates. Minimisation will be carried out using the free software Minim. (Altman and Bland, 2005). In minim interface, we will create two treatment groups as intervention and control. Sex and age will be our two covariates(factor). For sex factor two categories will be there as male and female. For age five categories as10,12,13,14,15 yrs

Next Version

2.Randomization a) Minimisation method, which is a type of covariate adaptive randomization, will be utilized to allocate the participants to intervention and control groups. Age and sex will be the covariates considered. The first participant will be randomly assigned to either the treatment or control group. Each subsequent participant will be assigned to study groups (intervention and control) using a minimisation method to ensure balance in age and sex covariates. Minimisation will be carried out using the free software Minim. (Altman and Bland, 2005). In minim interface, we will create two treatment groups as intervention and control. Sex and age will be our two covariates(factor). For sex factor two categories will be there as male and female. For age five categories as10,11,12,13,14 yrs