The particulars supplied shall take the following form: ...
(c) details of the trial protocol giving a description of the methods used, including methods of randomization and blinding, details such as the route of administration, schedule of administration, the dose, identification of trial animals, species, breeds or strains, age, weight, sex, physiological status ...
Clinical trials should be blinded (whenever feasible), controlled and animals should be allocated randomly to test and control groups. The details of the blinding method used should be provided.
