and route of administration, ingredient or route of administration Comparable formulation dosing details, dosing details and dose form and dose form formulation Relevance to Traditional Traditional Some differences target population is population is between differences or population identical to the comparable to the traditional differences of target target population population and uncertain population target populations clinical but significance ‘clinically reasonable’ to exist between extrapolate traditional evidence to the and target target population populations Relevance to The wording of The wording of The wording for The wording traditional the indication is the indication is the indication is and intent for health identical to item identical in intent identical in intent the indication benefit of evidence, to item of to item of is including, the evidence, evidence, but trial inconsistent use of traditional including, the use contemporary with the item terminology. of traditional terminology of evidence. terminology (modern synonym (traditional used to describe synonym used to the traditional describe the indication). indication). Relevance to Clearly identified Identified within Identified within Not traditional and used the relevant the relevant consistent context continuously traditional traditional with the within the paradigm but with paradigm with relevant relevant disclarity some disclarity traditional traditional regarding regarding paradigm paradigm over at consistency of use characterisation of 75 years over a period of the active 75 years ingredients or formulation 4. Quality of evidence (Section 3.2.2.6)
and route of administration administration, Comparable dosing details, dose form and formulation ingredient or formulation dosing details and dose form route of Relevance to target population Traditional population is identical to the target population Traditional population is comparable to the target population Some differences between traditional population and target populations but ‘clinically reasonable’ to extrapolate evidence to the target population differences or differences of uncertain clinical significance exist between traditional and target populations Relevance to traditional health benefit The wording of the indication is identical to item of evidence, including, the use of traditional terminology. The wording of the indication is identical in intent to item of evidence, including, the use of traditional terminology (traditional synonym used to describe the indication). The wording for the indication is identical in intent to item of evidence, but contemporary terminology (modern synonym used to describe the traditional indication). The wording and intent for the indication is inconsistent with the item of evidence. Relevance to traditional context Clearly identified and used continuously within the relevant traditional paradigm over at 75 years Identified within the relevant traditional paradigm but with disclarity regarding consistency of use over a period of 75 years Identified within the relevant traditional paradigm with some disclarity regarding characterisation of the active ingredients or formulation Not consistent with the relevant traditional paradigm 4. Quality of evidence (Section 3.2.2.6) trial
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