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Article History

Received: 23 May 2024

Accepted: 29 November 2024

First Online: 11 December 2024

Declarations

:

: This is a retrospective study conducted using data previously collected by Danone Nutricia Research. All studies were conducted in compliance with the principles of the Declaration of Helsinki and with the local laws and regulations of the countries where the studies were performed. All participating study centers in each individual study obtained approval from their relevant Ethical Review Boards, please see below for further details. Informed consent was obtained from parents or caregivers before study enrollment and data collection. Since the objective of the current analyses are in line with the primary objectives of the individual studies to evaluate growth patterns in early life, the parental consent provided in each individual study serves as basis for the current pooled data analyses. However, in several included studies, the informed consent even contains a statement that the collected data can be used for future research (beyond the scope of the original study), to avoid the need to re-contact participants after finalization of the trial.

: The study was conducted in compliance with the principles of the ‘Declaration of Helsinki’ (52nd WMA General Assembly, Edinburgh, Scotland, October 2000) and with the local German laws and regulations. The study was retrospectively registered in a public clinical trial database: ISRCTN23993517. All communication regarding the Ethics Committee is in German. Approval from several Ethics Committees were obtained including Ethics Committee Ruhr-Universität Bochum, Bochum; Ethics Committee Bayrischen Landesärztekammer, München; Ethics Committee ÄKN Ärztekammer Niedersachsen, Hannover; Ethics Committee Landesärztekammer Baden-Württemberg, Stuttgart; Ethics Committee Landesärztekammer Thüringen, Jena; Ethics Committee Ärztekammer Westfalen, Münster; Ethics Committee der Ärztekammer Nordrhein, Düsseldorf; Ethics Committee der Ärztekammer Nordrhein, Mönchengladbach.

: The study was conducted following the principles of the Declaration of Helsinki and Good Clinical Practice guidelines. The protocol was approved by the Ethics Committees of the different institutes in the countries. In Indonesia, the study protocol was reviewed and approved by Ethics Committee Ministry of national education faculty of medicine Gadjah mada university medical and health research ethics committee with approval number KE/FK/69/EC on date 18.09.2012. In Thailand, the study protocol was reviewed and approved by Ethics Committee The Ethical Review Committee for Research in Human Subjects Ministry of Public Health Thailand with approval number 22/2555 on date 25.07.2012 and approved by Ethics Committee Faculty of Medicine, Prince of Songkla University with approval number 55-285-01-1-1 on date 20.08.2012 and by Ethical Committee and by Ethics Committee INSTITUTIONAL REVIEW BOARD Faculty of Medicine, Chulalongkorn University 1873 Rama 4 Road, Patumwan, Bangkok 10330, Thailand, with approval number 262/55 on date 24.07.2012 by Ethics Committee Khon Kaen University Princess Mother Memorial Building Faculty of Medicine, Khon Kean, 40002 Thailand with approval number HE551184 on date 24.07.2012.

: The study was conducted following the principles of the Declaration of Helsinki and Good Clinical Practice guidelines. In Thailand, the study protocol was reviewed and approved by Ethics Committee INSTITUTIONAL REVIEW BOARD Faculty of Medicine, Chulalongkorn University, 1873 Rama4 Road, Patumwan, Bangkok 10330, Thailand with approval number 499/55 on date 01.22.2013 and approved by Ethics Committee Ethics Approval of Institutional Review Board, Royal Thai Army Medical Department 317 Rajavithi Road, Rajathevee, Bangkok 10400 with approval number IRB/RTA 222/2556 on date 01.22.2013 and Human Research Ethics Committee of Thammasat University, Prathumthani 12121 Thailand with approval number 089/2556 on date 12.09.2013.

: The study was conducted following the principles of the Declaration of Helsinki and Good Clinical Practice guidelines. The protocol was approved by the Ethics Committees of the different institutes in the countries. In Germany, the study protocol was reviewed and approved by Ethics Committee Landesarztekammer Brandenburg, Hauptgeschaftsstelle Postfach 10 14 45, 03014 Cottbus with approval numbers Nr. 10/1870 (S 12(a)/2010 on date 03.08.2010. In Italy, the study protocol was reviewed and approved by Ethics Committee A.C. petJllll Ci i1i di Brescia. P.le Spedali Cií1i. I -25123 Bresl’ill with approval number CAX.1.C/A on date 08.07.2010.

: The study was conducted following the principles of the Declaration of Helsinki and Good Clinical Practice guidelines. The protocol was approved by the Ethics Committees of the different institutes in the countries. In France the study protocol was reviewed and approved by Ethics Committee AFSSAPS FACULTE DE MEDECINE BP 87900 21079 DIJON CEDEX with approval number N2010-A00951-38 on date 30.12.2010. In Belgium, the study protocol was reviewed and approved by Ethics Committee COMMISSIE MEDISCHE ETHIEK Laarbeeklaan 101 1090 BRUSSEL with approval number 2011/219 Am on 26.01.2012. In Ireland, the study protocol was reviewed and approved by Ethics Committee COISTE EITICE UM THAIGHDE CLINICIUIL, Lancaster Hall, 6 Little Hanover Street, Cork, Ireland with approval number ECM 3 (n) 05/10/10 on date 09.09.2010 and The National Maternity Hospital Ethical committee holles street Dublin 2 with approval number on date 26.10.2010. In Tunisia, the study protocol was reviewed and approved by Ethics Committee Comite d’Ethique de l’hopital MONGI SLIM Sidi Daoud 2046 La Marsa Tunis on date 03.09.2010, and Ethics Committee Comite d’Ethique de l’hopital Charles Nicolle Boulevard 9 avril 1938-1006 Unis on date 30.08.2010 and Ethics Committee Comite d’Ethique de l’hopital Farhat Hached Avenew lbn El Jazzar 4000 Sousse Tunisie on date 15.09.2010 and Ethics Committee Comite d’Ethique de l’hopital Hedi Chaker Avenue Majida boulila 30229-Sfax Tunisie on 27.08.2010 and Comite dÉthique du centre de Maternite et de Neonatologie de Tunis El Jabbari 1007-Tunis on 29.09.2010 and Comite d’Ethique de l’hopital Militaire de Tunis Montfleury 1008- tunis on 07.12.2010.

: The study was conducted following the principles of the Declaration of Helsinki and Good Clinical Practice guidelines. The protocol was approved by the Ethics Committees in Belgium Comite d’Ethique Hospitalo-Facultaire ROUTE DE LENNIK 808 - B-1070 BRUXELLES with approval number GIRAFFE, ALL.3 C/A, P2010/184 on date 29.06.2010.

: The study was conducted following the principles of the Declaration of Helsinki and Good Clinical Practice guidelines. The protocol was approved by the Ethics Committees of the different institutes in the countries. In Thailand, the study protocol was reviewed and approved by Ethics Committee Institutional review board faculty of medicine Chulalonkorn University 1873 Rama 4 Road, Patumwan Bangkok 108330 Thailand with approval number COA No. 767/2012 IRB No. 437/55 on date 08.11.2012. In Singapore, the study protocol was reviewed and approved by Ethics Committee SingHealth 31 Third Hospital Avenue 03-03 Bowyer Block C 168753 Singapore with approval number CIRB ref 2010/832/E on date 02.03.2011.

: The study was conducted following the principles of the Declaration of Helsinki and Good Clinical Practice guidelines. The protocol was approved by the Ethics Committees of the different institutes in the countries. In Spain, the study protocol was reviewed and approved by Ethics Committee CONSEJERIA DE SALUD Direccion General de Calidad, Investigacion y Gestion del Conocimiento Comite Coordin ador de Etlca de la Investigacion Blomedlca de Andalucia Al A SRA, Luz Ruiz Hern dndez Cl. S Pau, 18 1o lu 08629 Torrelles de Llobregat (Barcelona) with approval number 5500 on date 07.02.2012. In Italy, the study protocol was reviewed and approved by Ethics Committee Azielda ospedaliera ospedale di circolo e Foadazione Macchi - Polo Universitario viale Borri 57- 2 I I 00 Varese with approval number 13 on date 03.04.2012 and by Ethics Committee Azielda ospedaliera istituti clinici di perezionamento Milano Dott. Gianluca LISTA Buzzi - Patologia Neonatale via Castelvetro 32 with approval number 355 on 15.02.2012 and by ethical committee Comitato Etico Indipendente dell’Azienda Ospedaliero-Universitaria di Bologna Via Endrico Ferni 15 00044 Frascati ROMA with approval number 212/2012/O/Sper on date 12.02.2013.

: The study was conducted following the principles of the Declaration of Helsinki and Good Clinical Practice guidelines. The protocol was approved by the Ethics Committees of the different institutes in the countries. In Belgium, the study protocol was reviewed and approved by Ethics Committee COMMISSIE MEDISCHE ETHIEK Laarbeeklaan 101 1090 BRUSSEL with approval number 2012/252 on date 05.12.2012. In France, the study protocol was reviewed and approved by Ethics Committee COMITE DE PROTECTION DES PERSONNES DU SUD-OUEST ET OUTRE-MER IV Hôpital Jean Rebeyrol - Avenue du Buisson - 87042 LIMOGES CEDEX with approval number N CPP13-005/2013-A00098-37 on date 21.03.2013. In the Netherlands study protocol was reviewed and approved by Ethics Committee IRBNijmegen 6700 CA Wageningen with approval number IRBN2012015 HdJ 13 on date 26.07.2016.

: The study was conducted following the principles of the Declaration of Helsinki and Good Clinical Practice guidelines. The protocol was approved by the Ethics Committees of the different institutes in the countries. In Italy, the study protocol was reviewed and approved by Ethics Committee Ministero della salute dipartimento per valutazione medicinali e per la farmacovigilanza Ufficio sperimentazione clinica Via della Civilta Romana n. 7 00100 Roma with approval number NRG/11/DbCoRPMc/IC inf 01 (protocol nr) on date 27.04.2006. In Germany, the study protocol was reviewed and approved by Ethics Committee Charite Ethikausschuss 2 der Ethikkommission Schumannstr 20/21 10098 Berlin with approval number EA2/174/05 on date 19.10.2006. In the Netherlands, the study protocol was reviewed and approved by Ethics Committee Medisch Ethische Toetsingscommissie Universitair Medisch Centrum Groningen Hanzeplein 1 9700 Groningen with approval number METc2005/123 on date 25/08/2005. In Austria, the study protocol was reviewed and approved by Ethics Committee Land Salszburg gesundheit und hygiene Sebastian stief gasse 2 with approval number 9/11-E648/3-2006 on date 27.02.2006. In Switzerland, the study protocol was reviewed and approved by Ethics Committee Ethik-Kommission (KEK) Obstgartenstrasse 21 8090 Zurich with approval number StV-25/05 on date 29.09.2005.

: The study was conducted following the principles of the Declaration of Helsinki and Good Clinical Practice guidelines. The protocol was approved by the Ethics Committees of the different institutes in the countries. In UK, the study protocol was reviewed and approved by Ethics Committee NHS Research ethics committees (A) park street Shirley Southampton Hampshire SO16 4RJ with approval number 05/Q1702/119 on date 03.11.2005. In Ireland, the study protocol was reviewed and approved by Ethics Committee Coiste eitice um thaighde cliniciuil Lancaster Hall 6 Hanover Street Cork Ireland with approval number ECM 3(s) 04/12/07 on date 02.11.2007. In Singapore, the study protocol was reviewed and approved by Ethics Committee KK Womens and Childrens Hospital SingHealth IRB with approval number EC200610143 on date 21.12.2006.

: The study was conducted following the principles of the Declaration of Helsinki and Good Clinical Practice guidelines. In the Netherlands the study protocol was reviewed and approved by Ethics Committee Medisch Ethische Commissie AMC Meibergdreef 9 1105 AZ Amsterdam with approval number MEC 05/055 05.17.0614 on date 28.04.2005.

: The study was conducted following the principles of the Declaration of Helsinki and Good Clinical Practice guidelines. In Singapore the study protocol was reviewed and approved by Ethics Committee National Healthcare group 6 commonwealth lane level 6 GMTI building Singapore 149547 with approval number 2011/01838 on 17.11.2011.

: The derived data set was fully anonymized.

: The authors have no relevant financial or non-financial interests to disclose. Floor Van Oudenhoven, Marieke Abrahamse Berkeveld, Shila Shafaeizadeh, and Sophie Swinkels are employees of Danone Nutricia Research.