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Page 9, lines 8-10: State the repeatability SD values supporting this assertion. Page 9, lines 30-32: State

the repeatability SD values supporting this assertion. Page 9, lines 42-44: State the repeatability SD

values supporting this assertion. Page 10, lines 7-9: State the repeatability SD values supporting this

assertion. Page 10, lines 21-23: State the repeatability SD values supporting this assertion. Page 10 lines

42-44: State the repeatability SD values supporting this assertion. Add the requested repeatability SD

values as footnotes to relevant Tables.

ER 8

Applicability statement is too general. Tables are not properly footnoted.

Supporting Data and Information: Does data from collaborative study support the method as written?

ER 1

Yes.

ER 2

Yes

ER 3

Yes

ER 4

Yes

ER 5

yes

ER 6

Yes

ER 7

Yes, in general.

ER 8

Yes.

Supporting Data and information: Does data collected support the criteria given in the collaborative study protocol?

ER 1

The data supports the criteria.

ER 2

Yes

ER 3

No

ER 4

yes

ER 5

yes

ER 6

Yes

ER 7

Yes.

ER 8

Yes.

Are there any concerns regarding the safety of the method?

ER 1

To be covered once Safety Advisor review is presented.

ER 2

No

ER 3

No

ER 4

No

ER 5

No

ER 6

No

ER 7

No.

ER 8

No.

Are there any concerns regarding the data manipulation, data tables, or statistical analysis?

ER 1

No concerns.

ER 2

No

ER 3

The manuscript would be much stronger if a more detail rational is given as to why some of the

collaborative labs were excluded. It is understandable to have such occurrences in a large collaborative

study.

ER 4

No

ER 5

No

ER 6

No

ERP PROFILE SUMMARIES

137