Discontinued development programmes as evidence — amendment log
Every change made since protocol registration, with its date and reason.
§5Amendment log
Every change made to this review after protocol registration is recorded below with its date and its reason. A change that is not in this log did not happen. The Institute publishes the log in full, including changes that did not alter a conclusion, because a reader cannot judge which changes matter unless all of them are visible.
§5.1Amendment log
Table 9. Amendments to this review since protocol registration.
| Date | Version | Amendment | Record |
|---|---|---|---|
| 24 Dec 2023 | 0.1 | Protocol registered | The review protocol was registered with the Institute’s secretariat before the search was executed. No change to the review question was made after registration. |
| 17 May 2024 | 1.1 | Analysis method changed | The pooling method was changed from a fixed-effect to a random-effects model following observation of between-study heterogeneity exceeding the pre-specified threshold. |
| 20 Jan 2025 | 1.2 | Comment-period disposition applied | Amendments arising from the disposition of a public comment period were applied. Each amendment is traceable to a numbered submission. |
| 23 Aug 2025 | 1.3 | Outcome added | An additional outcome was added at the request of a public comment-period respondent. The addition is recorded here because it was made after protocol registration and is therefore post hoc. |
| 18 Mar 2026 | 1.0 | Study reclassified | A study previously included was reclassified as ineligible following retrieval of the full report. The quantitative synthesis was re-run without it. |
| Current version 1.1, ratified in the 2024 Q2 assessment cycle. | |||
§5.2Clinical study report requests
Table 10. Clinical study reports requested for the contributing trials, and the outcome of each request. Refusals are recorded because a review that does not record them presents the sponsor's disclosure decision as the Institute's own.
| Trial | Requested | Outcome |
|---|---|---|
| DANU-PH2B-OBESITY | 06 Nov 2023 | Refused |
| DANU-PH2B-T2D | 06 Dec 2023 | Redirected to a data-access portal |
| CELIAC-PH3-CEDLARA | 27 Dec 2023 | Partially supplied |
| MMPOWER-3 | 03 Jan 2024 | Supplied on request |
| ELAM-PH2-HFPEF | 03 Nov 2023 | No response |
| MMPOWER-2 | 29 Dec 2023 | Partially supplied |
| AOD-OA-PH2 | 19 Dec 2023 | Refused |
| CELIAC-PH2B | 26 Nov 2023 | Redirected to a data-access portal |
§5.3Superseded versions
Superseded versions of this review remain published at a stable address, are marked as superseded, and link forward to the current version. The current version links back to each of them. That practice was adopted following a submission that a document cited in the literature must remain retrievable in the form in which it was cited; the reasoning is published on the corrections policy disposition page.