Statistically significant parameter/endpoint	Finding	GMO Panel interpretation
Body weight, body weight gain, food consumption	Statistically significant Increases and decreases at different time periods (± 50%)	Sporadic changes at individual time points. No significant impact on body weight or body weight gain over the entire study period. Not an adverse effect of treatment.
Mean corpuscular haemoglobin concentration	Statistically significant decrease in females (1%)	Low magnitude, not adverse in isolation, no other significant changes in red cell parameters, not present in males, within normal variation. Not an adverse effect of treatment.
Lymphocyte and basophil as % of WBC count	Statistically significant decrease in males (10–50%).	No significant change in absolute counts. Likely secondary to a high value for neutrophils (see below). Not an adverse effect of treatment.
Neutrophil % and absolute count	Statistically significant increases in males (40–60%)	Within the normal variation seen in rats of the same supplier, strain, age and basal diet, as shown by in depth evaluation of HCD from the test facility supplied (additional information 7/6/2021). No evidence of histopathology changes in myeloid/lymphoid organs (e.g. thymus, spleen, lymph nodes, Peyer's patches) or of inflammation. Not an adverse effect of treatment.
ALT activity	Statistically significant decrease in males (15%).	Decrease is not adverse in isolation, no consistent pattern in other liver marker enzymes and no liver pathology findings. Not an adverse effect of treatment.
Calcium	Statistically significant increase in females (3%).	Low magnitude, values for all 3 groups (11.3, 11.5 and 11.6) are near or above the upper end of the historic control range (11.4). Not an adverse effect of treatment.
Chloride	Statistically significant decrease in males (1%).	Low magnitude, within normal variation. Not an adverse effect of treatment.
Liver weights (absolute and relative to brain weights)	Statistically significant increase in males (10–20%)	Partially related to a higher body weight, not significant relative to body weight and with no associated clinical chemistry or pathological findings. Not an adverse effect of treatment.
Spleen weights (absolute and relative to brain weights)	Statistically significant increase in males (10–15%).	Low magnitude, no associated haematology or pathological findings. Not an adverse effect of treatment.