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The DSMC will act in accordance with internationally recognised guidelines, review the protocol prior to study initiation, and evaluate study conduct and the occurrence of adverse events at specific time points throughout the trial (ie, after 50% and 100% of recruitment, and after the completion of each follow-up visit). Dissemination of results and data access The results of this trial will be published in peer-reviewed journals, presented at various national and international fora, and communicated to international agencies, such as the WHO, who have taken a leadership role in MDV3100 developing global health policies pertaining to deworming in high-risk population groups. Following completion of the study, project data will initially be used by the research team to prepare the manuscripts and other standard scientific dissemination products. The final trial data set will be available for consultation and available via direct requests to the principal investigator (TWG). Footnotes Contributors: All authors made a significant contribution to the formation and design of the study protocol. The protocol was written by LSM and TWG and was critically reviewed by MC, AM, ER, WDF, GSM, JV, and LHA. All authors gave approval for publication. Funding: This work is supported by the Bill and Melinda Gates Foundation, grant number OPP1066903, the International Development Research Centre, grant number 106690-9990675-052, and the Canadian Institutes of Health Research Michael Smith Foreign Study Supplement, grant number 124574. Prior to initiation of the RCT fieldwork, the Foundation assisted the investigators in providing expert opinion and subsequently, in organising annual meetings of all teams in the Healthy Growth competition to share knowledge and offer efficiencies in terms of administrative support. Once initiated, no change was made to the trial protocol. Competing interests: None declared. Patient consent: Obtained. Ethics approval: Ethics approvals for protocol V.2.0 (26 August 2013) have been obtained from the Research Ethics Boards of the McGill University Health Centre in Canada; and the Asociaci��n Civil Impacta and the Instituto Nacional de Salud (Peruvian Institute of Health) in Peru. Provenance and peer review: Not commissioned; peer reviewed for ethical and funding approval prior to submission. Data sharing statement: Following completion of the study, project data will initially be used by the research team to prepare the manuscripts and other standard scientific dissemination products. The final trial data set will be available for consultation and publically available via direct requests to the principal investigator.""According to the Organisation for Economic Co-operation and Development (OECD) health statistics data, the age-standardised suicide mortality rate in 2011 was 33.3 per 100?000 individuals.1 2 Among all OECD countries, this is the highest value, while the rate of increase in suicidal mortality remains constant.