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Trial registered on ANZCTR

Registration number

ACTRN12609000734268

Ethics application status

Approved

Date submitted

19/08/2009

Date registered

25/08/2009

Date last updated

28/07/2024

Date data sharing statement initially provided

12/06/2019

Date results provided

12/06/2019

Type of registration

Retrospectively registered

Titles & IDs

Public title

The Melbourne Atopy Cohort Study (MACS): A Randomised controlled trial of a partially hydrolysed whey and a soy formula for the prevention of allergic disease.

Scientific title

In children with a family history of allergic disease does consumption of a partially hydrolysed whey or a soy formula at the cessation or partial cessation of breastfeeding, when compared to conventional cows’ milk formula reduce the incidence of allergic disease

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

MACS

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Allergic manifestations
Eczema
Asthma
Allergic rhinitis
Atopy

Condition category

Condition code

Inflammatory and Immune System

Allergies

Diet and Nutrition

Other diet and nutrition disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Arm 1: Partially hydrolysed whey formula (Nan HA) given as required, at the cessation, or partial cessation of breastfeeding, up to 12 months of age. Administered orally after mixing 4.4g of powdered formula to every 30 ml of warm water.
Arm2: Soy formula (Prosobee) given as required, at the cessation, or partial cessation of breastfeeding, up to 12 months of age. Administered orally after mixing 4.4g of powdered formula to every 30 ml of warm water

Intervention code [1]

Prevention

Comparator / control treatment

Conventional cows' milk formula (NAN) given as required, at the cessation, or partial cessation of breastfeeding, up to 12 months of age. Administered orally after mixing 4.3g of powdered formula to every 30 ml of warm water

Control group

Active

Outcomes

Primary outcome [1]

Allergic manifestations (eczema, food reactions, urticaria) assessed by telephone interview of parent

Timepoint [1]

up to 2 years age. Telephone interviews were undertaken 18 times during the first two years of life (every 4 weeks until 64 weeks, then at 78 and 104 weeks)

Secondary outcome [1]

eczema (assessed by telephone interview of parent)

Timepoint [1]

up to 2 years age. Telephone interviews were undertaken 18 times during the first two years of life (every 4 weeks until 64 weeks, then at 78 and 104 weeks)

Secondary outcome [2]

atopy (positive skin prick test)

Timepoint [2]

6, 12, and 24 months of age, and 12, 18 and 25 years

Secondary outcome [3]

eczema assessed by questionnaire designed specifically for this study at all time points, and using the validated International Study of Asthma and Allergies in Childhood questions at the 12, 18 and 25 year follow-up.

Timepoint [3]

5-7, 12, 18 and 25 years of age. A questionnaire was conducted when the child was six, seven, 12, 18 and 25 years of age, At 12 years and younger, questions were asked of parents. At 18 and 25 years, participants were asked directly. The quesionnaire asked if the participant had had any episodesof eczema in the previous 12 months.

Secondary outcome [4]

asthma assessed by questionnaire designed specifically for this study at all time points, and using the validated International Study of Asthma and Allergies in Childhood questions at the 12, 18 and 25 year follow-up.

Timepoint [4]

Secondary outcome [5]

allergic rhinitis assessed by questionnaire designed specifically for this study at all time points and using the validated International Study of Asthma and Allergies in Childhood questions at the 12, 18 and 25 year follow-up.

Timepoint [5]

5-7, 12, 18 and 25 years of age. A questionnaire was conducted when the child was six, seven, 12, 18 and 25 years of age, At 12 years and younger, questions were asked of parents. At 18 and 15 years, participants were asked directly. The quesionnaire asked if the participant had had any episodesof asthma in the previous 12 months.

Secondary outcome [6]

Lung function as assessed by spirometry

Timepoint [6]

12, 18 and 25 years

Eligibility

Key inclusion criteria

Family history of allergic disease (asthma, eczema, allergic rhinitis or severe food allergy)

Minimum age

0 Years

Maximum age

0 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Nil

Study design

Purpose of the study

Prevention

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Mother-baby pairs were allocated to the next sequential number on the allocation list as they were enrolled in the study, and were assigned to the formula code allocated to that number. The tins of formula were labeled at an independent location with a code number. Neither the study staff or particpants knew which formula was assigned to each tin code number.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Simple randomisation by using a randomisation table created by a computer program

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Active, not recruiting

Date of first participant enrolment

Anticipated

1/01/1990

Actual

8/01/1990

Date of last participant enrolment

Anticipated

1/11/1994

Actual

15/07/1994

Date of last data collection

Anticipated

31/12/2030

Actual

Sample size

Target

620

Accrual to date

Final

620

Recruitment in Australia

Recruitment state(s)

VIC

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Nestec Ltd,

Address [1]

Avenue Nestle 55 CH - 180-0 Vevey

Country [1]

Switzerland

Funding source category [2]

Government body

Name [2]

National Health and Medical Research Council (NHMRC)

Address [2]

GPO Box 1421
Canberra ACT 2601

Country [2]

Australia

Funding source category [3]

Charities/Societies/Foundations

Name [3]

Victorian Asthma Foundation

Address [3]

491-495 King Street, West Melbourne
Victoria, 3003

Country [3]

Australia

Primary sponsor type

Commercial sector/Industry

Name

Nestec Ltd,

Address

Avenue Nestle 55 CH - 180-0 Vevey

Country

Switzerland

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Mercy Hospital Human Research Ethics Committee

Ethics committee address [1]

Mercy Hospital for Women 163 Studley Road HEIDELBERG VIC 3084

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

19/01/1989

Ethics approval number [1]

Summary

Brief summary

Despite a lack of clear evidence, partially hydrolysed whey formula has been recommended at the cessation of exclusive breast-feeding in infants at high risk of developing allergic disease.  It is thought that partially hydrolysed whey formula may promote oral tolerance and prevent allergic diseases. Similarly, soy formula has previously been recommended for allergy prevention.  The primary aim of this study was to determine if the use of a partially hydrolysed formula, or a soy formula, at the cessation, or partial cessation of breastfeeding, reduced the incidence of allergic manifestations (eczema, urticaria and food reactions), in high-risk infants when compared with a conventional cows’ milk formula.

Trial website

Trial related presentations / publications

1. Tang MLK, Kemp AS, Thorburn J, Hill DJ. Reduced IFNy secretion in neonates and subsequent atopy. Lancet 1994;344:983-5.
2. Hill DJ, Hosking CS, Yu Zhie C, Leung R, Baratwidjaja K, Iikura Y, et al. The frequency of food allergy in Australia and Asia. Environ Toxicol and Pharma 1997;4:101-10.
3. Hill DJ, Sporik RS, Thorburn J, Hosking CS. The Association of Atopic Dermatitis in Infancy with Immunoglobulin E Food Sensitization. J Pediatr 2000;137:475-9.
4. Stoney RM, Woods RK, Hosking CS, Hill DJ, Abramson MJ, Thien FC. Maternal breast milk long-chain n-3 fatty acids are associated with increased risk of atopy in breastfed infants. Clin Exp Allergy 2004;34:194-200.
5. Hill DJ, Hosking CS. Food Allergy and Atopic Dermatitis in Infancy: an epidemiological study. Pediatr Allergy Immunol 2004;15:421-7.
6. Lowe AJ, Carlin JB, Bennett CM, Abramson MJ, Hosking CS, Hill DJ, et al. Atopic disease and breastfeeding - cause or consequence? J Allergy Clin Immunol 2006;117:682-7.
7. Lowe AJ, Abramson MJ, Hosking CS, Carlin JB, Bennett CM, Dharmage SC, Hill DJ. The temporal sequence of allergic sensitization and onset of infantile eczema. Clin Exp Allergy 2007;37:536-42.
8. A.J. Lowe, C.S. Hosking, C.M. Bennett, J.B. Carlin, M.J. Abramson, D.J. Hill, S.C. Dharmage Skin prick test can identify eczematous infants at risk of asthma and allergic rhinitis. 2007 Clin Exp Allergy
9. Hosking CS, Hill DJ, Thorburn J. Dharmage S. Does infection enhance or suppress the development of the atopic status? - a study of rhinitis in atopy-prone infants. Pediatric Asthma Allergy and Immunology 2007; 20(4): 223-228
10. Koplin J, Dharmage SC, Gurrin L, Osborne N, Tang ML, Lowe AJ, Hosking C, Hill D, Allen KJ. Soy consumption is not a risk factor for peanut sensitization. J Allergy Clin Immunol. 2008; 121:1455-9.
11. Lowe AJ, Carlin JB, Bennett CM, Hosking CS, Abramson MJ, Hill DJ, Dharmage SC. Do boys do the atopic march while girls dawdle? J Allergy Clin Immunol. 2008;121: 1190-5.
12. Lowe AJ, Thien FCK, Stoney RM, Bennett CM, Hosking CS, Hill DJ, Carlin JB, Abramson MJ, Dharmage SC. Associations between fatty-acids in colostrum and breast-milk and risk of allergic disease. Clinical and Experimental Allergy. 2008; 38:1745-1751.
13. Lodge CJ, Lowe AJ, Gurrin LC, Matheson MC, Balloch A, Axelrad C, et al. Pets at birth do not increase allergic disease in at-risk children. Clin Exp Allergy 2012; 42:1377-85.
14. Lowe AJ, Hosking CS, Bennett CM, Allen KJ, Axelrad C, Carlin JB, et al. Effect of a partially hydrolyzed whey infant formula at weaning on risk of allergic disease in high-risk children: A randomized controlled trial. J Allergy Clin Immunol 2011; 128:360-5.
15. Lodge CJ, Lowe AJ, Gurrin LC, Hill DJ, Hosking CS, Khalafzai RU, et al. House dust mite sensitization in toddlers predicts current wheeze at age 12 years. J Allergy Clin Immunol 2011; 128:782-8 e9.
16. Seach KA, Dharmage SC, Lowe AJ, Dixon JB. Delayed introduction of solid feeding reduces child overweight and obesity at 10 years. Int J Obes (Lond) 2010; 34:1475-9.
17. Lowe AJ, Carlin JB, Bennett CM, Hosking CS, Allen KJ, Robertson CF, et al. Paracetamol use in early life and asthma: prospective birth cohort study. BMJ 2010; 341:c4616.
18. Lodge CJ, Lowe AJ, Gurrin LC, Matheson MC, Balloch A, Axelrad C, Hill DJ, Hosking CS, Rodrigues S, Svanes C, Abramson MJ, Allen KJ, Dharmage SC: Pets at birth do not increase allergic disease in at-risk children. Clinical & Experimental Allergy, 2012, 42: 1377-1385.
19. Erbas B, Lowe A, Lodge C, Matheson M, Hosking C, Hill D, Vicendese D, Allen K, Abramson M, Dharmage S. Persistent pollen exposure during infancy is associated with increased risk of subsequent childhood asthma and hay fever. Clin Exp Allergy, 2013, 43(3): 337-43.
20. Lodge C, Zaloumis S, Lowe AL, Gurrin LC, Matheson MC, Axelrad C, Bennett CM, Hill D, Hosking C, Svanes C, Abramson MJ, Allen KJ, Dharmage SC. Early-life risk factors for childhood Wheeze phenotypes in a high-risk birth cohort. Journal of Paediatrics. 2014; 164: 289-294.
21. Lodge C, Lowe AL, Allen KJ, Zaloumis S, , Gurrin LC, Matheson MC, Axelrad C, Welsh L, Bennett CM, Hopper J, Thomas PS, Hill D, Hosking C, Svanes C, Abramson MJ, Dharmage SC. Some early childhood wheeze phenotypes are associated with reduced lung growth in adolescence. American Journal of Respiratory and Critical Care Medicine. 2014; 189: 1351-58. 
22. Alduraywish S, Lodge C, Vicendese D, Lowe A, Erbas B, Matheson M, Hopper J, Hill D, Axelrad C, Abramson M, Dharmage S, Allen K. Sensitization to milk, egg and peanut from birth to 18 years: a longitudinal study of a cohort at risk of allergic disease. Pediatric Allergy and Immunology. 2016; 27(1) 83-91.
23. Bowatte G, Lodge C, Lowe A, Erbas B, Dennekamp M, Marks G, Perret J, Hui J, Wjst M, Gurrin L, Allen K, Abramson M, Matheson M, Dharmage S. Do Variant s in GSTs Modify the Association between Traffic Air Pollution and Asthma in Adolescence? International Journal of Molecular Sciences. 2016; 17, 485.
24. Waidyatillake NT, Simpson JA, Allen KJ, Lodge CJ, Dharmage SC, Abramson MJ, De Livera AM, Matheson MC, Erbas B, Hill DJ, Lowe AJ. The Effect of Breastfeeding on Lung Function at 12 and 18 Years – a prospective cohort study. European Respiratory Journal. 2016;48(1):125-132.
25. Fuertes E, Markevych I, Bowatte G, Gruzieva O, Gehring U, Becker A, Berdel D, von Berg A, Bergström A, Brauer M, Brunekreef B, Brüske I, Carlsten C, Chan-Yeung M, Dharmage SC, Hoffmann B, Klümper C, Koppelman GH, Kozyrskyj A, Korek M, Kull I, Lodge C, Lowe A, MacIntyre E, Pershagen G, Standl M, Sugiri D, Wijga A, MACS, Heinrich J. Residential greenness is differentially associated with childhood allergic rhinitis and aeroallergen sensitization in seven birth cohorts. Allergy; 2016; 10: 1461-71.
26. Alduraywish SA, Standl M, Lodge CJ, Abramson MJ, Allen KJ, Erbas B, v. Berg A, Heinrich J, Lowe AJ, Dharmage SD. Is there a march from early food sensitization to later childhood allergic airway disease? Results from two prospective birth cohort studies, Pediatric Allergy and Immunology. 2017; 28: 30-7.
27. Lowe AJ, Lodge CJ, Allen KJ, Abramson MJ, Matheson MC, Thomas PS, Barton CA, Bennett C, Erbas B, Svanes C, Wjst M, Real FG, Perret J, Russell M, Southey M, Hopper J, Gurrin L, Axelrad C, Hill D, Dharmage S . The Melbourne Atopy Cohort study (MACS) - Cohort profile. International Journal of Epidemiology. 2017; 46(1): 25-26.
28. Waidyatillake NT, Stoney R, Thien F, Lodge CJ, Simpson JA, Allen KJ, Abramson MJ, Erbas B, Svanes C, Dharmage SC, Lowe AJ. Breast milk poly unsaturated fatty acids: associations with adolescent allergic disease and lung function. Allergy. 2017; 72: 1193-1201.
29. Dai X, Dharmage SC, Lowe AJ, Allen KJ, Thomas PS, Perret J, Waidyatillake N, Matheson MC, Svanes C, Welsh L, Abramson MJ, Lodge CJ. Early smoke exposure is associated with asthma and lung function deficits in adolescents. J Asthma. 2017; 54(6): 662-9.
30. Lowe AJ, Angelica B, Su J, Lodge CJ, Hill DJ, Erbas B, Bennett CM, Gurrin LC, Axelrad C, Abramson MJ, Allen KJ, Dharmage SC. Age at onset and persistence of eczema are related to subsequent risk of asthma and hay fever from birth to 18 years of age. Pediatr Allergy Immunol. 2017; 28: 384-390.
31. Ashley SE, Tan HTT, Vuillermin P, Dharmage SC, Tang MLK, Koplin J, Gurrin LC, Lowe AJ, Lodge C, Ponsonby AL, Molloy J, Martin P, Matheson MC, Saffery R, Allen KJ, Ellis JA, Martino D and the HealthNuts team. The skin barrier function gene SPINK5 is associated with challenge proven IgE-mediated food allergy in infants. Allergy. 2017: 72; 1356-64.
32. Peters RL, Koplin JJ, Allen KJ, Lowe AJ, Lodge C, Tang MLK, Wake M, Ponsonby AL, Erbas B, Abramson MJ, Hill D, Gurrin LC, Dharmage SC. The prevalence of food sensitization appears not to have changed between two Melbourne cohorts of high-risk infants recruited 15 years apart. Clinical Immunology – In practice. 2018: 6;440-448.e2.
33. Susanto NH, Malby Schoos AN, Standl M, Lowe AJ, Dharmage SC, Svanes C, Salim A, von Berg A, Lehmann I, Rasmussen MA, Werchan M, Bergmann KA, Lodge C, Abramson MJ, Heinrich J, Bisgaard H, Erbas B. Environmental grass pollen levels in utero and at birth and Cord Blood IgE: Analysis of three birth cohorts. Environmental International. 2018: 119; 295-301
34. Lowe AJ, Dharmage SC Abramson MJ, Vijayasarathy S, Erbas B, Mueller JF, Lodge CJ.  Cord-serum per- and poly-fluoroalkyl substances (PFAS) and atopy and eczema at 12-months.  Allergy.  2019; 74; 812-5. 
35. Lowe AJ, Wang X, Mueller JF, Abramson MJ, Yeh RY, Erbas B, Dharmage SC*, Lodge CJ*.  *Equal senior authors.  Exposure to breast-milk triclosan and parabens and eczema phenotypes at 12-months: a nested case-control study.  Journal of Allergy and Clinical Immunology.  2019: 144;1136-8.e6.
36. Aldakheel FM, Bourke JE, Thomas PS, Matheson MC, Abramson MJ, Hamilton GS, Lodge CJ, Thompson BR, Walters HE, Allen KJ, Erbas B, Perret JL, Dharmage SC, Lowe AJ.  NOx in exhaled breath condensate is related to allergic sensitization in young and middle-aged adults.  Clin Exp Allergy.  2019: 49; 171-9. 
37. Alduraywish SA, Luzak A, Lodge CJ, Aldakheel F, Erbas B, Allen KJ, Matheson, Gurrin L, Heinrich J, Lehmann I, v. Berg A, Standl M, Abramson MJ, Schulz H, Lowe AJ*, Dharmage SD*. * Equal senior.  The role of early life food sensitization in adolescent lung function: Results from two birth cohort studies.  JACI: In Practice Journal. 2019; 7; 1825-34. 
38. Barton C, Dharmage SC, Lodge C, Abramson MJ, Erbas B, Lowe AJ.  Asthma, atopy and serious psychological distress: prevalence and risk factors among young people in the Melbourne Atopy Cohort Study.  Journal of Asthma.  2019. 
39. Tham R, Erbas B, Dharmage SC, Tang MLK, Aldakheel FM,  Lodge C, Thomas PS, Taylor P, Abramson MJ, Lowe AJ.  Outdoor fungal spores and acute respiratory effects in vulnerable individuals.  Environmental Research.  2019: 178; 108675.
40. Dai X, Dharmage SC, Bowatte G, Waidyatillake NT, Perret JL, Hui J, Erbas B, Abramson MJ, Lowe AJ,  Burgess JA, Svanes C, Lodge CJ.  Interaction of glutathione S-transferase M1, T1 and P1 genes with early life tobacco smoke exposure on lung function in adolescents.  Chest. 2019: 155: 94-102 
41. Dumas O, Le Moual N, Lowe AJ, Lodge CJ, Zock J-P, Kromhout H, Erbas B Perret JL, Dharmage SD, Benke G, Abramson MJ.   Influence of childhood asthma and allergies on occupational exposure in early adulthood: a prospective cohort study. International Journal of Environmental Research and Public Health.  2019: 16; 2163. 
42. Lambert KA, Lodge C, Lowe AJ, Prendergast  L, Thomas PS, Bennett CM, Abramson MJ, Dharmage SC, Erbas B.  Pollen exposure at birth and adolescent lung function, and modification by residential greenness.  Allergy.  2019;74(10):1977-1984.
dos Santos K, Lodge C, Abramson M, Erbas B, Bennett C, Hui J, Dharmage S, Lowe A.  Early life exposure to oral antibiotics and lung function into early adulthood.  Chest.  2020; 157; 334-41.
43. Lowe AJ, Lee B, Orchard D, King E, Abramson MJ, Allen KJ, Hui J, Southey MC, Lodge CJ, Dharmage SC.  Palm reading and water divining: A cross-sectional study of the accuracy of palmar hyper-linearity and trans-epidermal water loss to identify individuals with a filaggrin gene null mutation.  Journal of the American Academy of Dermatology.  Accepted 23/1/2020. 
44. Dai X, Dharmage SC, Abramson MJ, Erbas B, Bennett C, Svanes C, Hui J, Axelrad C, Lowe AJ*,  Lodge CJ* (equal senior).  Early life acetaminophen exposure, Glutathione S-Transferase genes and development of adolescent asthma in a high-risk birth cohort.  Journal of Allergy and Clinical Immunology.  Accepted 1/4/2020.
45. Lodge C, Lowe A, Milanzi E, Bowatte G, Abramson M, Tsimilkis H, Axelrad C, Robertson B, Darling AE, Svanes C, Wjst M, Dharmage S, Bode L. Human Milk Oligosaccharide profiles and allergic disease up to 18 years in the MACS Cohort.  Journal of Allergy and Clinical Immunology.  Provisionally accepted 21/5/2020.  
46. Pape K, Schlünssen V, Lodge CJ, Perret J, Walters EH, Bui DS, Erbas B, Svanes C, Hamilton GS, Thomas PS, Hougaard KS, Abramson MJ, Dharmage SC, Lowe AJ,. Is self-reported history of eczema and hay-fever a valid measure of atopy in those who report current asthma?  Allergy.  Accepted 31/5/2020.
47. Lodge C, Lowe A, Abramson M, Svanes C, Zaloumis S, Thomas P, Dharmage S.  Transient childhood wheeze is associated with less atopy in adolescence. Pediatric Allergy and Immunology.  Accepted 2/6/2020.

Public notes

Contacts

Principal investigator

Name

Prof Shyamali Dharmage

Address

Centre for Epidemiology and Biostatistics
Melbourne School of Population and Global Health
L3, 207 Bouverie Street
University of Melbourne VIC 3010

Country

Australia

Phone

+61 3 83440737

Fax

s.dharmage@unimelb.edu.au

Contact person for public queries

Name

Dr David Hill

Address

Senior Consultant Allergist
Murdoch Children's Research Institute
The Royal Children’s Hospital
Flemington Road Parkville Victoria 3052

Country

Australia

Phone

+61 3 8344 0878

Fax

davidjlhill@bigpond.com

Contact person for scientific queries

Name

Dr David Hill

Address

Senior Consultant Allergist
Murdoch Children's Research Institute
The Royal Children’s Hospital
Flemington Road Parkville Victoria 3052

Country

Australia

Phone

+61 3 8344 0878

Fax

davidjlhill@bigpond.com

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

Consent for release of IPD has not been obtained

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Dimensions AI	No reason to change the current guidelines on allergy prevention	2011	https://doi.org/10.1016/j.jaci.2011.08.038
Embase	Do variants in GSTs modify the association between traffic air pollution and asthma in adolescence?.	2016	https://dx.doi.org/10.3390/ijms17040485
Embase	The effect of breastfeeding on lung function at 12 and 18 years: A prospective cohort study.	2016	https://dx.doi.org/10.1183/13993003.01598-2015
Embase	Early smoke exposure is associated with asthma and lung function deficits in adolescents.	2017	https://dx.doi.org/10.1080/02770903.2016.1253730
Embase	Interaction of Glutathione S-Transferase M1, T1, and P1 Genes With Early Life Tobacco Smoke Exposure on Lung Function in Adolescents.	2019	https://dx.doi.org/10.1016/j.chest.2018.08.1079
Embase	Transient childhood wheeze is associated with less atopy in adolescence.	2020	https://dx.doi.org/10.1111/pai.13304

N.B. These documents automatically identified may not have been verified by the study sponsor.

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