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Additional file 3: Appendix 3. Quality of life questionnaires

Additional file 1: Appendix 1. Outcomes definitions

Additional file 4: Supplement 1: Tables. Table 1: Schedule of Assessments for Screening. Table 2: Schedule of Assessments for: Weekly Paclitaxel alone. Table 3: Schedule of Assessments for Weekly Paclitaxel plus TAK228. Table 4: Baseline Characteristic Variables. Table 5: Laboratory parameters. Table 6: Listing of ���Most Common��� Adverse Events.

Additional file 2: Appendix 2. Interim analysis

Additional file 5: Supplement 2: Figure. Figure 1: Planned CONSORT Diagram.

Background Treatment for ovarian cancer includes platinum-based chemotherapy, but many women become resistant to chemotherapy, becoming platinum-resistant. Standard of care for these women is weekly paclitaxel chemotherapy, but cancers can often become paclitaxel resistant. TAK228, an investigational dual TORC1/2 inhibitor, is an oral therapy that can be added to standard treatment. The DICE trial is a phase II international multicentre, parallel-group, superiority clinical trial with 1:1, open label randomisation which has the aim of investigating the effectiveness of TAK228 plus weekly paclitaxel. The planned sample size is 124 women (62 per treatment arm) with platinum-resistant ovarian cancer. Objective To outline the planned analyses for DICE in a statistical analysis plan (SAP) before database hard lock and the start of analysis. This ensures that bias is minimised during the analysis phase. Results This SAP provides detailed descriptions of the analysis principles and statistical procedures for analysing primary and secondary outcomes of the trial. The primary outcome is overall progression-free survival (PFS). Secondary outcomes include progression-free survival (PFS) at 24 weeks, overall response rate (ORR), duration of response (DoR), time to progression (TTP), clinical benefit rate (CBR) at 4 months, Cancer Antigen 125 (CA125) response according to Gynaecological Cancer Intergroup (GCIG) criteria, overall survival (OS), safety and tolerability as assessed by adverse events and the quality-of-life questionnaires (EORTC QLQ-C30 and EORTC QLQ-OV28). This detailed description includes significance levels, sensitivity analyses and compliance analysis. Discussion The DICE trial will determine whether the addition of TAK228 to weekly paclitaxel chemotherapy shows a statistically significant improvement to participant’s progression free and overall survival and that the adverse events (AEs) and quality of life (QoL) are not significantly worse than the standard treatment. The study commenced recruitment in September 2018. An interim analysis was performed in early 2021, the results of which advised continuation of the trial. The study recruitment is ongoing and is due to complete by the end of 2021. Trial registration ClinicalTrials.govNCT03648489. Registered on 27 August 2018

La portée des deux livres En dépit des conseils de Michel Tournier, qui m’a écrit un jour dans une carte postale « Je ne vous conseille pas ce métier ingrat » de traducteur, j’ai traduit pour les presses de l’université du Nebraska Le Miroir des idées (The Mirror of Ideas) en 1998 et Éléazar, ou La Source et le Buisson (Eleazar, Exodus to the West) en 2002. Avant d’aborder les problèmes de la traduction littéraire aux États-Unis, j’aimerais d’abord discuter l’intérêt de ces deux œuvre...

L'œuvre de Michel Tournier a, depuis plus de quarante ans, donné lieu à de très nombreuses traductions dans les diverses langues européennes, même les plus rares, comme l'estonien, le géorgien, mais aussi en hébreu, en chinois, en japonais, en thaï... Ses livres, particulièrement les contes, ont été illustrés par des artistes français tels Georges Lemoine, Alain Gauthier, Claude Lapointe, Alain Letort. Or les traductions, comme les illustrations, sont des interprétations à travers lesquelles se profilent les multiples facettes d'un écrivain que nous renvoient en miroir des contextes spatio-temporels différents. Ce livre fait entendre la voix de ceux qui ont contribué à la réception de cette œuvre multiple et qui sont à des titres divers les « passeurs » nécessaires : journalistes, traducteurs, illustrateurs, enseignants chercheurs, venus de tous les continents. Le langage des mythes explique-t-il cette large diffusion par-delà les frontières géographiques et culturelles ? Ce livre se propose d'étudier la diversité des images que Michel Tournier donne de lui-même : écrivain géographique, voyageur ou sédentaire, écrivain classique, reconnu ou subversif, conteur, philosophe, chrétien.

The original version of this Article omitted a declaration from the competing interests statement, which should have included the following: ‘One of the authors, Y.L., is an editor on the staff of Nature Communications, but was not in any way involved in the journal review process. The other authors declare no competing interests’. This has now been corrected in both the PDF and HTML versions of the Article.