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Clinical Trial

1) NovaFerrum now clinically proven to be safe, efficacious, and well tolerated.*

2) NovaFerrum now clinically proven to be superior to Ferrous Sulfate in compliance and adherence.*

Primary Outcomes:

* Efficacy: 

– NovaFerrum raised hemoglobin from 7.7 to 11.1 g/dl at goal Results, sentence 2 and Figure 2/

* Tolerability: 

– More parents reported vomiting in the ferrous sulfate group compared to the NovaFerrum group throughout the trial (looking at Table 4).

* Adverse Effects: 

– Less difficulty in giving medication at week 6(P=0.01), week 8(P=0.002), week 10(P=0.03) Table 4

* Medication Adherence: 

– Successful dose administrations: 94% of parents with children receiving NovaFerrum reported that their child did not spit out the medication compared to only 82% of those getting ferrous sulfate.  The P = 0.009.

– No missed doses 78% PIC v. 53% FS(P=0.12)

* Compliance

– In Table 4, under “difficulty in giving medication” – again you can see that throughout the trial more parents reported difficulty in giving the medication in the ferrous sulfate group.  This was significant in the week 6 and 10-time points.

* QD Dosing

– Efficacy on QD dosing (Discussion Paragraph Six)

* Secondary Outcomes:

* With regard to signs/symptoms of anemia – pallor, energy, pica – both groups had improvement/resolution in similar proportions (Table Two)

*NovaFerrum was clinically proven to be safe, effective and well tolerated with children ages four and under.

* NovaFerrum was clinically proven to be superior to FS in Compliance and Adherence.

* Effect of Low-Dose Ferrous Sulfate vs Iron Polysaccharide Complex on Hemoglobin Concentration in Young Children With Nutritional Iron-Deficiency Anemia: A Randomized Clinical Trial

Jaquelyn M. Powers, MD, MS; George Buchanan, MD; Leah Adix; Son Zhang, PhD; Ang Gao, MS; Timothy L. McCavit, MD, MS

JAMA June 13, 2017 Volume 317, Number 22